Trial Outcomes & Findings for A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) (NCT NCT03656718)

Last Updated: 2025-11-12

Results Overview

Cmax is the maximum observed serum nivolumab concentration. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

139 participants

Primary outcome timeframe

From first dose until approximately 21 days post first dose.

Results posted on

2025-11-12

Participant Flow

28 participants from Part A and Part B crossed over after completing treatment in their originally assigned Arms to form Part C.

Participant milestones

Participant milestones
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part C - Nivolumab SC + rHuPH20 1200 mg Q4W Some participants in Part A and Part B crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Pre-Treatment Period STARTED	22	18	10	17	0	36	36
Pre-Treatment Period COMPLETED	22	18	10	17	0	36	36
Pre-Treatment Period NOT COMPLETED	0	0	0	0	0	0	0
Treatment Period Parts A, B, D, and E STARTED	22	18	10	17	0	36	36
Treatment Period Parts A, B, D, and E COMPLETED	10	6	5	9	0	7	6
Treatment Period Parts A, B, D, and E NOT COMPLETED	12	12	5	8	0	29	30
Treatment Period Part C STARTED	0	0	0	0	28	0	0
Treatment Period Part C COMPLETED	0	0	0	0	12	0	0
Treatment Period Part C NOT COMPLETED	0	0	0	0	16	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part C - Nivolumab SC + rHuPH20 1200 mg Q4W Some participants in Part A and Part B crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Treatment Period Parts A, B, D, and E Disease progression	8	11	4	6	0	20	21
Treatment Period Parts A, B, D, and E Study drug toxicity	2	1	1	2	0	4	1
Treatment Period Parts A, B, D, and E Death	1	0	0	0	0	0	2
Treatment Period Parts A, B, D, and E Adverse event unrelated to study drug	0	0	0	0	0	4	1
Treatment Period Parts A, B, D, and E Participant requested to discontinue study treatment	1	0	0	0	0	0	2
Treatment Period Parts A, B, D, and E Other reasons	0	0	0	0	0	1	3
Treatment Period Part C Disease progression	0	0	0	0	12	0	0
Treatment Period Part C Death	0	0	0	0	1	0	0
Treatment Period Part C Participant requested to discontinue study treatment	0	0	0	0	1	0	0
Treatment Period Part C Other reasons	0	0	0	0	1	0	0
Treatment Period Part C Maximum clinical benefit	0	0	0	0	1	0	0

Baseline Characteristics

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=36 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Total n=139 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=10 Participants	12 Participants n=10 Participants	5 Participants n=20 Participants	6 Participants n=45 Participants	14 Participants n=44 Participants	19 Participants n=8 Participants	62 Participants n=48 Participants
Age, Categorical >=65 years	16 Participants n=10 Participants	6 Participants n=10 Participants	5 Participants n=20 Participants	11 Participants n=45 Participants	22 Participants n=44 Participants	17 Participants n=8 Participants	77 Participants n=48 Participants
Sex: Female, Male Female	12 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=20 Participants	5 Participants n=45 Participants	10 Participants n=44 Participants	9 Participants n=8 Participants	47 Participants n=48 Participants
Sex: Female, Male Male	10 Participants n=10 Participants	13 Participants n=10 Participants	4 Participants n=20 Participants	12 Participants n=45 Participants	26 Participants n=44 Participants	27 Participants n=8 Participants	92 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	4 Participants n=44 Participants	1 Participants n=8 Participants	6 Participants n=48 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=10 Participants	5 Participants n=10 Participants	2 Participants n=20 Participants	7 Participants n=45 Participants	16 Participants n=44 Participants	22 Participants n=8 Participants	56 Participants n=48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=10 Participants	13 Participants n=10 Participants	8 Participants n=20 Participants	10 Participants n=45 Participants	16 Participants n=44 Participants	13 Participants n=8 Participants	77 Participants n=48 Participants
Race/Ethnicity, Customized White	18 Participants n=10 Participants	18 Participants n=10 Participants	8 Participants n=20 Participants	17 Participants n=45 Participants	31 Participants n=44 Participants	34 Participants n=8 Participants	126 Participants n=48 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants	0 Participants n=8 Participants	3 Participants n=48 Participants
Race/Ethnicity, Customized Other	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants	1 Participants n=8 Participants	8 Participants n=48 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants
Race/Ethnicity, Customized Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants	1 Participants n=8 Participants	2 Participants n=48 Participants

PRIMARY outcome

Timeframe: From first dose until approximately 21 days post first dose.

Population: All treated participants with available Cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=34 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Maximum Observed Serum Nivolumab Concentration (Cmax) - Parts A, B, D, and E	54.8 ug/mL Geometric Coefficient of Variation 51.0	56.6 ug/mL Geometric Coefficient of Variation 34.0	81.4 ug/mL Geometric Coefficient of Variation 41.0	63.9 ug/mL Geometric Coefficient of Variation 30.0	106.0 ug/mL Geometric Coefficient of Variation 46.0	57.8 ug/mL Geometric Coefficient of Variation 31.0	—

PRIMARY outcome

Timeframe: From first dose until approximately 21 days post first dose.

Population: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

Tmax is the time taken to reach the maximum observed serum nivolumab concentration (Cmax). Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=34 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Time Taken to Reach Cmax (Tmax) - Parts A, B, D, and E	167 hours Interval 47.0 to 357.0	167 hours Interval 50.1 to 339.0	141 hours Interval 47.2 to 333.0	168 hours Interval 139.0 to 355.0	130 hours Interval 44.5 to 317.0	130 hours Interval 45.2 to 337.0	—

PRIMARY outcome

Timeframe: From first dose until approximately 21 days post first dose.

Population: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be reported for Parts A, B, D, and E only.

AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. Collected for Arm A, B, and D on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15, and Cycle 1 Day 21. Collected for Arm E on Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 4, Cycle 1 Day 8, Cycle 1 Day 15.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=20 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=16 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=13 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=33 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=35 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Area Under the Time-Serum Nivolumab Concentration Curve (AUC (TAU)) - Parts A, B, D, and E	24908 h*ug/mL Geometric Coefficient of Variation 53	27909 h*ug/mL Geometric Coefficient of Variation 36	40264 h*ug/mL Geometric Coefficient of Variation 45	32702 h*ug/mL Geometric Coefficient of Variation 31	53561 h*ug/mL Geometric Coefficient of Variation 40	15857 h*ug/mL Geometric Coefficient of Variation 30	—

PRIMARY outcome

Timeframe: At the end of dosing interval of Cycle 1 - first dose (Day 21 for Parts A, B and D; Day 15 for Part E)

Population: All treated participants with available cycle 1 PK results in Parts A, B, D, and E. Pre-specified for data to be collected only in Parts A, B, D, and E.

Ctau is the observed serum nivolumab concentration at the end of the dosing interval. Collected for Arma A, B, and D.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=20 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=16 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=13 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=33 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=35 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Observed Serum Nivolumab Concentration at the End of Dosing (Ctau) - Parts A, B, D, and E	22.2 ug/mL Geometric Coefficient of Variation 86	26.9 ug/mL Geometric Coefficient of Variation 65	39.2 ug/mL Geometric Coefficient of Variation 67	34.8 ug/mL Geometric Coefficient of Variation 41	54.4 ug/mL Geometric Coefficient of Variation 49	43.6 ug/mL Geometric Coefficient of Variation 36	—

PRIMARY outcome

Timeframe: On Day 1 of Cycles 2, 3, 5, 9, 13, and 19 of Part C (Day 1 of Part C: up to 14 months from Baseline; each cycle was 28 days)

Population: All participants in Part C (who crossed over from Part A or B) with available PK results for each visit. Pre-specified for data to be reported for Part C crossover participants only. Participants are presented under their original treatment assignment.

Ctrough assessed during Part C. Ctrough is the lowest observed serum nivolumab concentration.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=7 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=6 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=2 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=8 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 9 Day 1	170 ug/mL Geometric Coefficient of Variation 55	138 ug/mL Geometric Coefficient of Variation 81	228 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate Geometric Coefficient of Variation.	208 ug/mL Geometric Coefficient of Variation 38	—	—	—
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 2 Day 1	115 ug/mL Geometric Coefficient of Variation 58	106 ug/mL Geometric Coefficient of Variation 42	124 ug/mL Geometric Coefficient of Variation 38	85.7 ug/mL Geometric Coefficient of Variation 48	—	—	—
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 3 Day 1	119 ug/mL Geometric Coefficient of Variation 51	118 ug/mL Geometric Coefficient of Variation 34	149 ug/mL Geometric Coefficient of Variation 42	104 ug/mL Geometric Coefficient of Variation 44	—	—	—
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 5 Day 1	149 ug/mL Geometric Coefficient of Variation 55	144 ug/mL Geometric Coefficient of Variation 66	192 ug/mL Geometric Coefficient of Variation 16	171 ug/mL Geometric Coefficient of Variation 8	—	—	—
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 13 Day 1	183 ug/mL Geometric Coefficient of Variation 34	113 ug/mL Geometric Coefficient of Variation 48	246 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate Geometric Coefficient of Variation.	217 ug/mL Geometric Coefficient of Variation 16	—	—	—
Lowest Observed Serum Nivolumab Concentration (Ctrough) During Part C - Part A and B Crossover Participants to Part C Cycle 19 Day 1	—	74.7 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate Geometric Coefficient of Variation.	—	212 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate Geometric Coefficient of Variation.	—	—	—

SECONDARY outcome

Timeframe: From first dose until 100 days post last dose (up to approximately 70 months).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

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

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Adverse Events (AEs)	22 Participants	18 Participants	10 Participants	17 Participants	27 Participants	36 Participants	36 Participants

SECONDARY outcome

Timeframe: From first dose until 100 days post last dose (up to approximately 70 months).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs)	14 Participants	10 Participants	8 Participants	11 Participants	16 Participants	27 Participants	28 Participants

SECONDARY outcome

Timeframe: From first dose until 100 days post last dose (up to approximately 70 months).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

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

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Serious Adverse Events (SAEs)	12 Participants	10 Participants	4 Participants	11 Participants	11 Participants	19 Participants	25 Participants

SECONDARY outcome

Timeframe: From first dose until 100 days post last dose (up to approximately 70 months).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Treatment Related Serious Adverse Events (TRSAEs)	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose until 100 days post last dose (up to approximately 70 months).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Treatment Related Adverse Events (TRAEs) Leading to Discontinuation	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: From randomization until data cutoff (up to approximately 70 months).

Population: All treated participants.

Number of participants who died due to any cause.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Who Died	18 Participants	14 Participants	8 Participants	14 Participants	17 Participants	25 Participants	30 Participants

SECONDARY outcome

Timeframe: From first dose until 30 days post last dose (up to approximately 67 months and 20 days).

Population: All treated participants with baseline and at least one on treatment laboratory measurement.

Laboratory parameters including hematology, chemistry, liver function, and renal function summarized using worst grade NCI CTCAE v.5 criteria. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=21 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=16 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=16 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants With Select Laboratory Changes From Baseline HYPERMAGNESEMIA (mmol/L)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPERNATREMIA (mmol/L)	2 Participants	1 Participants	1 Participants	2 Participants	5 Participants	4 Participants	3 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPOCALCEMIA (mmol/L)	5 Participants	2 Participants	2 Participants	2 Participants	2 Participants	4 Participants	5 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPOKALEMIA (mmol/L)	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants	5 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPOMAGNESEMIA (mmol/L)	5 Participants	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPONATREMIA (mmol/L)	8 Participants	4 Participants	5 Participants	3 Participants	9 Participants	9 Participants	13 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPOGLYCEMIA (mmol/L)	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Select Laboratory Changes From Baseline ALBUMIN, LOCAL LAB (g/L)	6 Participants	6 Participants	3 Participants	2 Participants	—	13 Participants	5 Participants
Number of Participants With Select Laboratory Changes From Baseline ACTIVATED PARTIAL THROMBOPLASTIN TIME (sec)	1 Participants	2 Participants	—	1 Participants	—	2 Participants	1 Participants
Number of Participants With Select Laboratory Changes From Baseline FIBRINOGEN (g/L)	0 Participants	0 Participants	—	0 Participants	—	0 Participants	0 Participants
Number of Participants With Select Laboratory Changes From Baseline HEMOGLOBIN (g/L)	13 Participants	7 Participants	3 Participants	8 Participants	15 Participants	12 Participants	12 Participants
Number of Participants With Select Laboratory Changes From Baseline PLATELET COUNT (10^9/L)	2 Participants	5 Participants	0 Participants	2 Participants	5 Participants	6 Participants	4 Participants
Number of Participants With Select Laboratory Changes From Baseline LEUKOCYTES, LOCAL LAB (10^9/L)	1 Participants	5 Participants	1 Participants	1 Participants	7 Participants	3 Participants	3 Participants
Number of Participants With Select Laboratory Changes From Baseline ABSOLUTE NEUTROPHIL COUNT DRV. (10^9/L)	2 Participants	2 Participants	1 Participants	2 Participants	5 Participants	2 Participants	3 Participants
Number of Participants With Select Laboratory Changes From Baseline LYMPHOCYTES (ABSOLUTE) (10^9/L)	—	3 Participants	—	2 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Select Laboratory Changes From Baseline LYMPHOCYTES (ABSOLUTE), LOCAL LAB (10^9/L)	10 Participants	9 Participants	5 Participants	5 Participants	12 Participants	7 Participants	16 Participants
Number of Participants With Select Laboratory Changes From Baseline CREATININE, LOCAL LAB (umol/L)	7 Participants	1 Participants	3 Participants	2 Participants	8 Participants	8 Participants	12 Participants
Number of Participants With Select Laboratory Changes From Baseline ALKALINE PHOSPHATASE (ALP) LOCAL LAB (U/L)	7 Participants	6 Participants	3 Participants	9 Participants	8 Participants	18 Participants	20 Participants
Number of Participants With Select Laboratory Changes From Baseline ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB (U/L)	6 Participants	8 Participants	3 Participants	7 Participants	9 Participants	7 Participants	11 Participants
Number of Participants With Select Laboratory Changes From Baseline ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB (U/L)	5 Participants	9 Participants	4 Participants	6 Participants	6 Participants	11 Participants	14 Participants
Number of Participants With Select Laboratory Changes From Baseline BILIRUBIN, TOTAL, LOCAL LAB (umol/L)	2 Participants	6 Participants	1 Participants	2 Participants	5 Participants	4 Participants	6 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPERCALCEMIA (mmol/L)	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	6 Participants	3 Participants
Number of Participants With Select Laboratory Changes From Baseline HYPERKALEMIA (mmol/L)	7 Participants	4 Participants	4 Participants	2 Participants	9 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: From first dose until 2 days post last dose (up to approximately 66 months and 22 days).

Population: All treated participants who received nivolumab subcutaneously (SC) and/or nivolumab intravenously (IV).

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration Nivolumab administered subcutaneously (SC) +/- rHuPH20	1 Participants	1 Participants	0 Participants	0 Participants	4 Participants	3 Participants	8 Participants
Number of Participants Experiencing Any Select Adverse Events Within the Hypersensitivity/Infusion Reaction Category and Broad Standardized MedDRA Query (SMQ) of Anaphylactic Reaction Occurring Within 2 Days of Study Drug Administration Nivolumab administered intravenously (IV)	2 Participants	2 Participants	1 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: At baseline and up to 100 days post last dose (up to approximately 70 months).

Population: Immunogenicity Evaluable Participants: All treated participants in Parts A-E who have a baseline and at least 1 post-baseline immunogenicity assessment.

Anti-drug antibody (ADA) Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment; Neutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected post-baseline. Baseline ADA Positive: A participant with a baseline ADA-positive sample. Baseline refers to evaluations with a date on or prior to the day of first dose of study treatment.

Outcome measures

Outcome measures
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=21 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 2: Nivolumab SC 720mg n=18 Participants Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part B - Group 4: Nivolumab SC 960mg n=17 Participants Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=28 Participants Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=35 Participants Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies NEUTRALIZING POSITIVE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies ANTI-DRUG ANTIBODY (ADA) POSITIVE	7 Participants	5 Participants	3 Participants	0 Participants	7 Participants	5 Participants	10 Participants
Number of Participants With Anti-Nivolumab Antibodies (ADAs) and Neutralizing Antibodies BASELINE ANTI-DRUG ANTIBODY (ADA) POSITIVE	2 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants

Adverse Events

Part A - Group 1: Nivolumab + rHuPH20 SC 720mg

Serious events: 12 serious events

Other events: 22 other events

Deaths: 18 deaths

PART A - GRP 1 CROSSOVER to PART C

Serious events: 4 serious events

Other events: 9 other events

Deaths: 6 deaths

Part B - Group 2: Nivolumab SC 720mg

Serious events: 10 serious events

Other events: 18 other events

Deaths: 14 deaths

PART B - GRP 2 CROSSOVER to PART C

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Part B - Group 3: Nivolumab + rHuPH20 SC 960mg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 8 deaths

PART B - GRP 3 CROSSOVER to PART C

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Part B - Group 4: Nivolumab SC 960mg

Serious events: 11 serious events

Other events: 17 other events

Deaths: 14 deaths

PART B - GRP 4 CROSSOVER to PART C

Serious events: 4 serious events

Other events: 8 other events

Deaths: 5 deaths

Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W

Serious events: 19 serious events

Other events: 34 other events

Deaths: 25 deaths

Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W

Serious events: 25 serious events

Other events: 35 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 participants at risk Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART A - GRP 1 CROSSOVER to PART C n=9 participants at risk Some participants in Part A crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 2: Nivolumab SC 720mg n=18 participants at risk Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 2 CROSSOVER to PART C n=6 participants at risk Some participants in Part B - Group 2 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 participants at risk Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 3 CROSSOVER to PART C n=5 participants at risk Some participants in Part B - Group 3 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 4: Nivolumab SC 960mg n=17 participants at risk Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 4 CROSSOVER to PART C n=8 participants at risk Some participants in Part B - Group 4 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=36 participants at risk Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 participants at risk Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Blood and lymphatic system disorders Anaemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Acute myocardial infarction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Atrial flutter	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Atrial thrombosis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Coronary artery disease	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Myocardial infarction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Myocarditis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Ascites	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Gastrointestinal haemorrhage	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Intestinal obstruction	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Intestinal perforation	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Pancreatitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Subileus	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Vomiting	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Death	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Fatigue	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders General physical health deterioration	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Pyrexia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Cholangitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Cholelithiasis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Hepatic failure	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Hepatitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Immune system disorders Contrast media allergy	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations COVID-19	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations COVID-19 pneumonia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Empyema	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Escherichia infection	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Lung abscess	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Pneumonia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 2/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	40.0% 2/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Pseudomonal sepsis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Sepsis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Urinary tract infection	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Hip fracture	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Alanine aminotransferase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Aspartate aminotransferase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood bilirubin increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Lipase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperkalaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected metastasis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	27.8% 5/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	23.5% 4/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	19.4% 7/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Vascular disorders Hypotension	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour fistulisation	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour obstruction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Brain stem haemorrhage	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Epilepsy	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Hypoaesthesia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Neuralgia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Paraesthesia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Spinal cord compression	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Product Issues Device dislocation	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Confusional state	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Acute kidney injury	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Tubulointerstitial nephritis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.

Other adverse events

Other adverse events
Measure	Part A - Group 1: Nivolumab + rHuPH20 SC 720mg n=22 participants at risk Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART A - GRP 1 CROSSOVER to PART C n=9 participants at risk Some participants in Part A crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 2: Nivolumab SC 720mg n=18 participants at risk Single dose of nivolumab (BMS-986298) 720 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 2 CROSSOVER to PART C n=6 participants at risk Some participants in Part B - Group 2 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 3: Nivolumab + rHuPH20 SC 960mg n=10 participants at risk Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 3 CROSSOVER to PART C n=5 participants at risk Some participants in Part B - Group 3 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part B - Group 4: Nivolumab SC 960mg n=17 participants at risk Single dose of nivolumab (BMS-986298) 960 mg administered subcutaneously (SC) without recombinant human hyaluronidase (rHuPH20) by syringe pump. Four weeks after the single nivolumab SC (BMS-986298) dose participants received IV nivolumab (BMS-936558) 480 mg Q4W dosing until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, completion of 104 weeks of treatment, cross over to nivolumab SC dosing in Part C, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	PART B - GRP 4 CROSSOVER to PART C n=8 participants at risk Some participants in Part B - Group 4 crossed over to Part C, four weeks after their last nivolumab IV dose to receive nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occured first.	Part D: Nivolumab SC + rHuPH20 SC 1200mg Q4W n=36 participants at risk Nivolumab (BMS-986298) 1200 mg administered subcutaneously (SC) with recombinant human hyaluronidase (rHuPH20) manually by syringe every 4 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.	Part E: Nivolumab SC Co-Formulated With rHuPH20 600mg Q2W n=36 participants at risk Nivolumab (BMS-986298) 600 mg coformulated with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) manually by syringe every 2 weeks. Treatment continued until Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 progression, unacceptable toxicity, withdrawal of consent, or completion of 104 weeks of treatment, whichever occurred first. In certain circumstances, participants with progressive disease per RECIST v1.1 but with otherwise stable or improved performance and clinical status could continue to be treated in the event of a perceived benefit per Investigator.
Cardiac disorders Palpitations	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Anaemia	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 6/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	30.0% 3/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	40.0% 2/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	19.4% 7/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Atrial fibrillation	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Tachycardia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Ear and labyrinth disorders Ear discomfort	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Endocrine disorders Adrenal insufficiency	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Endocrine disorders Hyperthyroidism	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Endocrine disorders Hypothyroidism	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 8/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 8/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Eye disorders Eye pruritus	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Eye disorders Lacrimation increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Abdominal pain	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Abdominal pain upper	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 2/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Autoimmune colitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Chronic gastritis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Constipation	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 3/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 2/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Diarrhoea	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 4/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	50.0% 3/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	23.5% 4/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Dry mouth	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 3/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Dyspepsia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Nausea	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 3/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 2/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 8/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Oesophagitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Stomatitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Subileus	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Vomiting	18.2% 4/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Asthenia	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	38.9% 7/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 8/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Chest pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Chills	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Facial pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Fatigue	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 3/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 3/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Influenza like illness	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site erythema	18.2% 4/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	60.0% 6/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	80.0% 4/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site pruritus	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site reaction	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	27.8% 10/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site swelling	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Mucosal inflammation	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Nodule	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Non-cardiac chest pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Oedema peripheral	31.8% 7/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 3/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 2/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Pyrexia	22.7% 5/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 6/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Secretion discharge	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Cholangitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Cholestasis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Hyperbilirubinaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Hepatobiliary disorders Hypertransaminasaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Immune system disorders Hypersensitivity	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Bronchitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations COVID-19	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Candida infection	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Cellulitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Ear infection	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Gastroenteritis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Herpes zoster	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Hordeolum	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Lower respiratory tract infection	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Nasopharyngitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Norovirus infection	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Oral candidiasis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Pilonidal disease	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Pneumonia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Rash pustular	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Rhinitis	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Skin infection	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Upper respiratory tract infection	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Urinary tract infection	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Immunisation reaction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Injection related reaction	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Skin laceration	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Alanine aminotransferase increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Amylase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Aspartate aminotransferase increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood albumin decreased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Weight decreased	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood alkaline phosphatase increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 4/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood bilirubin increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood creatine phosphokinase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood creatinine increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 6/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood lactate dehydrogenase increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Gamma-glutamyltransferase increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Hepatic enzyme increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Lipase increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Protein total decreased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Weight increased	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Decreased appetite	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hypercalcaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperglycaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperkalaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hypoalbuminaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Underweight	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Arthralgia	31.8% 7/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	44.4% 4/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	33.3% 2/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	29.4% 5/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	27.8% 10/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Arthritis	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Back pain	18.2% 4/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	37.5% 3/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	13.9% 5/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Ligament pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Muscle spasms	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Muscular weakness	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	17.6% 3/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Neck pain	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Rib deformity	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Dizziness	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Dizziness postural	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Dysgeusia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Headache	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	23.5% 4/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Monoparesis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Neuralgia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Neuropathy peripheral	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Paraesthesia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Agitation	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Anxiety	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Depressed mood	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Insomnia	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Haematuria	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Micturition urgency	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Urinary incontinence	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Vascular disorders Hypertension	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Urinary retention	9.1% 2/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Asthma late onset	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Cough	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	23.5% 4/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	37.5% 3/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	23.5% 4/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	8.3% 3/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Erythema	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Lividity	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Pruritus	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.9% 1/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	12.5% 1/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 8/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 9/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 2/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.8% 2/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	25.0% 2/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 4/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash erythematous	13.6% 3/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	22.2% 2/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash macular	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	10.0% 1/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	20.0% 1/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 2/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	5.6% 1/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	16.7% 1/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Granulomatous lymphadenitis	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Eye disorders Diplopia	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Lymph node pain	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Blood and lymphatic system disorders Lymphadenopathy	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Cardiac disorders Cardiac failure chronic	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Eye disorders Dry eye	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Eye disorders Periorbital swelling	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Abdominal pain lower	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Gastritis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Gastrointestinal disorders Gastrointestinal haemorrhage	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Gait disturbance	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
General disorders Injection site irritation	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Diverticulitis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Folliculitis	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Influenza	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Infections and infestations Tooth abscess	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Injury, poisoning and procedural complications Pelvic fracture	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Blood folate decreased	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Investigations Thyroxine free increased	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Fluid retention	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Tremor	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Gout	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Hypokalaemia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Metabolism and nutrition disorders Vitamin B12 deficiency	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Coccydynia	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Osteopenia	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Burning sensation	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Hyperaesthesia	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Hypoaesthesia	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Motor dysfunction	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Nervous system disorders Sciatica	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Product Issues Device dislocation	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Confusional state	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Delirium	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Depression	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Psychiatric disorders Sleep disorder	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Renal and urinary disorders Dysuria	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Reproductive system and breast disorders Vaginal haemorrhage	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Bronchospasm	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Decubitus ulcer	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Dermatitis	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Skin disorder	4.5% 1/22 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	11.1% 1/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/18 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/10 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/17 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Skin and subcutaneous tissue disorders Skin mass	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Vascular disorders Haemorrhage	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Vascular disorders Hypotension	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.
Vascular disorders Vena cava thrombosis	7.7% 1/13 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/12 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/6 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/5 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/9 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/8 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	2.8% 1/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.	0.00% 0/36 • All-cause Mortality was collected from randomization until the data cutoff date (approximately 70 months). SAEs and Other AEs were collected from the first dose until 100 days post the last dose (up to approximately 70 months). All-Cause Mortality, SAEs and Other AEs refer to all the participants who were treated with study medicine. For Cohort C crossover participants, data were reported according to the group from which they crossed over as prespecified.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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