Trial Outcomes & Findings for Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer (NCT NCT04305496)

NCT ID: NCT04305496

Last Updated: 2026-01-29

Results Overview

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort. Participants who discontinue treatment prior to progression should continue to be scanned until progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 818 participants
• Primary outcome timeframe: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.
• Results posted on: 2026-01-29

Participant Flow

A total of 708 participants in Global cohort (out of 818 participants in Global and China cohorts) were randomized to treatment. An additional 110 participants were enrolled into the China cohort only.

A total of 818 participants were enrolled in the study. However, 24 participants were in both the Global and China cohorts.

Participant milestones

Measure	Capivasertib + Fulvestrant Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Global Cohort STARTED	355	353
Global Cohort COMPLETED	63	43
Global Cohort NOT COMPLETED	292	310
China Cohort STARTED	71	63
China Cohort COMPLETED	18	10
China Cohort NOT COMPLETED	53	53

Reasons for withdrawal

Measure	Capivasertib + Fulvestrant Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Global Cohort Withdrawal by Subject	13	6
Global Cohort Physician Decision	1	1
Global Cohort Subjective disease progression	16	17
Global Cohort Condition under investigation worsened	209	273
Global Cohort Protocol Violation	2	0
Global Cohort Adverse Event	44	6
Global Cohort Death	3	2
Global Cohort Any reason not specifically recorded	4	5
China Cohort Any reason not specifically recorded	1	1
China Cohort Adverse Event	8	2
China Cohort Condition under investigation worsened	40	47
China Cohort Subjective disease progression	2	2
China Cohort Withdrawal by Subject	2	1

Baseline Characteristics

The results are presented by Global cohort and by China cohort

Baseline characteristics by cohort

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=410 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global Cohort + China Cohort ) n=408 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Total n=818 Participants Total of all reporting groups
Age, Continuous Global cohort	58.6 years STANDARD_DEVIATION 11.25 • n=355 Participants • The results are presented by Global cohort and by China cohort	57.4 years STANDARD_DEVIATION 11.91 • n=353 Participants • The results are presented by Global cohort and by China cohort	58.0 years STANDARD_DEVIATION 11.59 • n=708 Participants • The results are presented by Global cohort and by China cohort
Age, Continuous China cohort	54.7 years STANDARD_DEVIATION 10.66 • n=71 Participants • The results are presented by Global cohort and by China cohort	55.0 years STANDARD_DEVIATION 10.60 • n=63 Participants • The results are presented by Global cohort and by China cohort	54.8 years STANDARD_DEVIATION 10.59 • n=134 Participants • The results are presented by Global cohort and by China cohort
Age, Customized Global cohort · <50 years	76 Participants n=355 Participants • Overall population	99 Participants n=353 Participants • Overall population	175 Participants n=708 Participants • Overall population
Age, Customized Global cohort · >=50-<65 years	164 Participants n=355 Participants • Overall population	152 Participants n=353 Participants • Overall population	316 Participants n=708 Participants • Overall population
Age, Customized Global cohort · >=65-<75 years	91 Participants n=355 Participants • Overall population	76 Participants n=353 Participants • Overall population	167 Participants n=708 Participants • Overall population
Age, Customized Global cohort · >=75 years	24 Participants n=355 Participants • Overall population	26 Participants n=353 Participants • Overall population	50 Participants n=708 Participants • Overall population
Age, Customized China cohort · <50 years	19 Participants n=71 Participants • Overall population	24 Participants n=63 Participants • Overall population	43 Participants n=134 Participants • Overall population
Age, Customized China cohort · >=50-<65 years	39 Participants n=71 Participants • Overall population	21 Participants n=63 Participants • Overall population	60 Participants n=134 Participants • Overall population
Age, Customized China cohort · >=65-<75 years	12 Participants n=71 Participants • Overall population	18 Participants n=63 Participants • Overall population	30 Participants n=134 Participants • Overall population
Age, Customized China cohort · >=75 years	1 Participants n=71 Participants • Overall population	0 Participants n=63 Participants • Overall population	1 Participants n=134 Participants • Overall population
Sex: Female, Male Global cohort · Female	352 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	349 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	701 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Sex: Female, Male Global cohort · Male	3 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	4 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	7 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Sex: Female, Male China cohort · Female	71 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	62 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	133 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Sex: Female, Male China cohort · Male	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	1 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	1 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) Global cohort · Hispanic or Latino	31 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	31 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	62 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) Global cohort · Not Hispanic or Latino	323 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	322 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	645 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) Global cohort · Unknown or Not Reported	1 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	1 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) China cohort · Hispanic or Latino	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) China cohort · Not Hispanic or Latino	69 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	61 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	130 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Ethnicity (NIH/OMB) China cohort · Unknown or Not Reported	2 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	2 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	4 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · American Indian or Alaska Native	2 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	2 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	4 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · Asian	95 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	94 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	189 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · Native Hawaiian or Other Pacific Islander	1 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	1 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · Black or African American	4 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	4 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	8 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · White	201 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	206 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	407 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · More than one race	0 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) Global cohort · Unknown or Not Reported	52 Participants n=355 Participants • The results are presented by Global cohort and by China cohort	47 Participants n=353 Participants • The results are presented by Global cohort and by China cohort	99 Participants n=708 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · American Indian or Alaska Native	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · Asian	69 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	61 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	130 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · Native Hawaiian or Other Pacific Islander	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · Black or African American	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · White	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · More than one race	0 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	0 Participants n=134 Participants • The results are presented by Global cohort and by China cohort
Race (NIH/OMB) China cohort · Unknown or Not Reported	2 Participants n=71 Participants • The results are presented by Global cohort and by China cohort	2 Participants n=63 Participants • The results are presented by Global cohort and by China cohort	4 Participants n=134 Participants • The results are presented by Global cohort and by China cohort

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

Population: Overall population in the global cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort.

Participants who discontinue treatment prior to progression should continue to be scanned until progression.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=355 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=353 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Overall Population (Months) in the Global Cohort	7.2 Months Interval 5.5 to 7.4	3.6 Months Interval 2.8 to 3.7

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

Population: Overall population in the Global Cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).

Participants who discontinue treatment prior to progression should continue to be scanned until progression.

Kaplan-Meier estimate was used.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=355 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=353 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Overall Population (Percentage) in the Global Cohort PFS rate at 9 months	40.9 Percentage of participants Interval 35.6 to 46.1	24.4 Percentage of participants Interval 19.9 to 29.1
Progression Free Survival: Overall Population (Percentage) in the Global Cohort PFS rate at 6 months	51.8 Percentage of participants Interval 46.4 to 57.0	32.0 Percentage of participants Interval 27.0 to 37.0
Progression Free Survival: Overall Population (Percentage) in the Global Cohort PFS rate at 12 months	28.5 Percentage of participants Interval 23.7 to 33.5	18.4 Percentage of participants Interval 14.4 to 22.8

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

Population: Altered population in the Global Cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=155 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=134 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Altered Population (Months) in the Global Cohort	7.3 Months Interval 5.5 to 9.0	3.1 Months Interval 2.0 to 3.7

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

Population: Altered population in the Global Cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.

Kaplan-Meier estimate was used.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=155 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=134 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Altered Population (Percentage) in the Global Cohort PFS rate at 6 months	53.4 Percentage of participants Interval 45.1 to 60.9	29.6 Percentage of participants Interval 21.9 to 37.7
Progression Free Survival: Altered Population (Percentage) in the Global Cohort PFS rate at 9 months	42.0 Percentage of participants Interval 34.0 to 49.7	21.6 Percentage of participants Interval 14.9 to 29.1
Progression Free Survival: Altered Population (Percentage) in the Global Cohort PFS rate at 12 months	28.2 Percentage of participants Interval 21.2 to 35.6	15.8 Percentage of participants Interval 10.0 to 22.7

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

Population: Full analysis set in the China cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause, in the global cohort.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).

Participants who discontinue treatment prior to progression should continue to be scanned until progression.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=71 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=63 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Overall Population (Months) in the China Cohort	6.9 Months Interval 5.4 to 9.2	2.8 Months Interval 1.9 to 3.9

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression.

Population: Full analysis set in the China cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the longest diameter of target lesions (short axis diameter used for lymph nodes), or clinically significant increase in a non-target lesion, or the appearance of a new lesion(s).

Participants who discontinue treatment prior to progression should continue to be scanned until progression.

Kaplan-Meier estimate was used.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=71 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=63 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Overall Population (Percentage) in the China Cohort PFS rate at 6 months	53.9 Percentage of participants Interval 41.3 to 65.0	24.5 Percentage of participants Interval 14.6 to 35.8
Progression Free Survival: Overall Population (Percentage) in the China Cohort PFS rate at 9 months	40.9 Percentage of participants Interval 28.8 to 52.5	24.5 Percentage of participants Interval 14.6 to 35.8
Progression Free Survival: Overall Population (Percentage) in the China Cohort PFS rate at 12 months	29.6 Percentage of participants Interval 18.6 to 41.4	19.1 Percentage of participants Interval 10.3 to 29.9

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

Population: Altered subgroup full analysis set in the China cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=71 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=63 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Altered Population (Months) in the China Cohort	5.7 Months Interval 3.8 to 8.0	1.9 Months Interval 1.8 to 3.7

PRIMARY outcome

Timeframe: Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks.

Population: Altered subgroup full analysis set in the China cohort

Progression free survival (PFS), defined as the time from randomization until progression per RECIST v1.1, as assessed by the investigator at the local site, or death due to any cause

Kaplan-Meier estimate was used.

Outcome measures

Measure	Capivasertib + Fulvestrant (Global + China Cohort) n=71 Participants Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.	Placebo + Fulvestrant (Global + China Cohort) n=63 Participants Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off). Fulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Progression Free Survival: Altered Population (Percentage) in the China Cohort PFS rate at 6 months	46.3 Percentage of participants Interval 25.1 to 65.1	14.3 Percentage of participants Interval 3.6 to 32.1
Progression Free Survival: Altered Population (Percentage) in the China Cohort PFS rate at 9 months	23.1 Percentage of participants Interval 8.5 to 42.0	14.3 Percentage of participants Interval 3.6 to 32.1
Progression Free Survival: Altered Population (Percentage) in the China Cohort PFS rate at 12 months	6.9 Percentage of participants Interval 0.6 to 24.9	14.3 Percentage of participants Interval 3.6 to 32.1

Adverse Events

Capi (Global Cohort)

Serious events: 57 serious events

Other events: 334 other events

Deaths: 4 deaths

Placebo (Global Cohort)

Serious events: 28 serious events

Other events: 255 other events

Deaths: 1 deaths

Capi (China Cohort)

Serious events: 20 serious events

Other events: 67 other events

Deaths: 1 deaths

Placebo (China Cohort)

Serious events: 3 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Capi (Global Cohort) n=355 participants at risk Description (Arm-group)	Placebo (Global Cohort) n=350 participants at risk Description (Arm-group)	Capi (China Cohort) n=71 participants at risk Description (Arm-group)	Placebo (China Cohort) n=62 participants at risk Description (Arm-group)
Ear and labyrinth disorders Vertigo	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Cerebral haemorrhage	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Cerebral infarction	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Cerebrovascular accident	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Dizziness	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Abdominal pain	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Syncope	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Psychiatric disorders Confusional state	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Renal and urinary disorders Acute kidney injury	0.85% 3/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Renal and urinary disorders Hydronephrosis	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Renal and urinary disorders Nephrolithiasis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Renal and urinary disorders Renal failure	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Drug eruption	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Diarrhoea	1.7% 6/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Erythema multiforme	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.8% 2/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash erythematous	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 5/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash papular	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Vascular disorders Deep vein thrombosis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Haemorrhoids	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Ileus	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Nausea	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Blood and lymphatic system disorders Anaemia	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Retroperitoneal fibrosis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Stomatitis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Vomiting	1.1% 4/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.8% 2/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Asthenia	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Device intolerance	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Fatigue	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Pyrexia	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Visceral pain	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Hepatobiliary disorders Drug-induced liver injury	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Immune system disorders Anaphylactic reaction	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Immune system disorders Drug hypersensitivity	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Bacterial colitis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Bone tuberculosis	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Covid-19	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Cytomegalovirus infection	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Hepatitis b reactivation	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Herpes zoster	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Hordeolum	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Acute myocardial infarction	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Infectious pleural effusion	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Injection site abscess	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Peritonitis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Pneumonia	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Pneumonia aspiration	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Pneumonia bacterial	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Pneumonia pneumococcal	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Pyelonephritis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Sepsis	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Skin infection	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Atrial fibrillation	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Urinary tract infection	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Injury, poisoning and procedural complications Femur fracture	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Injury, poisoning and procedural complications Toxicity to various agents	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Aspartate aminotransferase increased	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Pericardial effusion	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood creatinine increased	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Body temperature increased	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Platelet count decreased	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Dehydration	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypercalcaemia	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hyperglycaemia	0.85% 3/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Supraventricular extrasystoles	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Arthralgia	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.

Other adverse events

Measure	Capi (Global Cohort) n=355 participants at risk Description (Arm-group)	Placebo (Global Cohort) n=350 participants at risk Description (Arm-group)	Capi (China Cohort) n=71 participants at risk Description (Arm-group)	Placebo (China Cohort) n=62 participants at risk Description (Arm-group)
Nervous system disorders Dysgeusia	5.9% 21/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.1% 4/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Nervous system disorders Headache	16.9% 60/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.3% 43/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Abdominal pain	5.9% 21/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.6% 9/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Psychiatric disorders Insomnia	6.2% 22/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.0% 21/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Renal and urinary disorders Proteinuria	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 5/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	16.9% 12/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.1% 5/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 17/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.7% 13/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.8% 2/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.7% 6/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Constipation	7.9% 28/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.3% 29/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.7% 6/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.0% 25/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.6% 23/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Dry skin	7.0% 25/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.3% 15/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Diarrhoea	71.8% 255/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	20.0% 70/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	60.6% 43/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 7/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Erythema	1.7% 6/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	12.4% 44/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.6% 23/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash	21.7% 77/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.3% 15/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	29.6% 21/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.6% 52/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.6% 9/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	25.4% 18/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Vascular disorders Hot flush	5.1% 18/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.4% 19/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Vascular disorders Hypertension	5.1% 18/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.7% 13/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Dry mouth	5.4% 19/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.6% 9/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Dyspepsia	5.1% 18/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.0% 7/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Mouth ulceration	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Nausea	34.4% 122/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	15.1% 53/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	14.1% 10/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Blood and lymphatic system disorders Anaemia	10.4% 37/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.6% 16/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	31.0% 22/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	17.7% 11/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Stomatitis	14.4% 51/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.9% 17/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.7% 9/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Gastrointestinal disorders Vomiting	19.7% 70/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.3% 15/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.9% 7/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Asthenia	12.7% 45/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	10.3% 36/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Fatigue	20.6% 73/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.9% 45/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Malaise	2.8% 10/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.0% 7/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.2% 3/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.9% 8/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
General disorders Pyrexia	9.0% 32/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.7% 13/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	22.5% 16/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Covid-19	5.9% 21/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.9% 10/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.7% 9/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.1% 5/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Upper respiratory tract infection	1.1% 4/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Infections and infestations Urinary tract infection	9.9% 35/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.6% 23/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	21.1% 15/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	19.4% 12/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Alanine aminotransferase increased	9.0% 32/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.6% 30/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	18.3% 13/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	33.9% 21/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Aspartate aminotransferase increased	9.3% 33/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.4% 33/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	14.1% 10/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	29.0% 18/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood alkaline phosphatase increased	3.7% 13/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.4% 12/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 7/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood bilirubin increased	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.1% 4/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood cholesterol increased	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 5/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood creatinine increased	4.5% 16/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.9% 7/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood thyroid stimulating hormone increased	1.4% 5/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.1% 4/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 8/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.1% 5/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Blood urea increased	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Electrocardiogram qt prolonged	0.85% 3/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Gamma-glutamyltransferase increased	3.4% 12/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Glucose urine present	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Glycosylated haemoglobin increased	1.4% 5/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	18.3% 13/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Sinus bradycardia	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Lymphocyte count decreased	1.7% 6/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Neutrophil count decreased	2.5% 9/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.3% 8/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	19.7% 14/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations Weight decreased	3.4% 12/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.3% 8/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	23.9% 17/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations White blood cell count decreased	1.7% 6/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.1% 4/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	21.1% 15/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.1% 5/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Investigations White blood cells urine positive	0.00% 0/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Decreased appetite	16.6% 59/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.3% 22/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 8/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Cardiac disorders Sinus tachycardia	1.1% 4/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	7.0% 5/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 5/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 8/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hyperglycaemia	15.8% 56/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.7% 13/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	57.7% 41/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	17.7% 11/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypernatraemia	0.28% 1/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	22.5% 16/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hyperuricaemia	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.1% 5/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypoalbuminaemia	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.86% 3/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 8/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 7/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypocalcaemia	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	11.3% 8/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypokalaemia	4.2% 15/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	25.4% 18/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	9.7% 6/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hyponatraemia	2.0% 7/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.57% 2/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	8.5% 6/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.5% 4/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Metabolism and nutrition disorders Hypophosphataemia	0.56% 2/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.29% 1/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	12.7% 9/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 33/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	10.9% 38/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.8% 2/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.6% 1/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	9.0% 32/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.9% 24/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	2.8% 2/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	4.8% 3/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	4.5% 16/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.1% 18/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	1.4% 1/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	0.00% 0/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 22/355 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	6.3% 22/350 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	5.6% 4/71 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.	3.2% 2/62 • Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented. Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
• Publication restrictions are in place

Restriction type: OTHER