Trial Outcomes & Findings for A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma (NCT NCT02519348)

NCT ID: NCT02519348

Last Updated: 2025-10-14

Results Overview

A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any \>= Grade 2 pneumonitis that does not resolve to \<= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to \<= Grade 1 or baseline within 14 days, liver transaminase elevation \> 8 × upper limit of normal (ULN) or total bilirubin \> 5 × ULN, aspartate aminotransferase or alanine aminotransferase \> 3 × ULN with concurrent increase in total bilirubin \> 2 × ULN without evidence of cholestasis or alternative explanations, and any \>= Grade 3 non-irAE (except for the protocol stated conditions).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 433 participants
• Primary outcome timeframe: From Day 1 to Day 28 after first dose of study drug
• Results posted on: 2025-10-14

Participant Flow

The results data are reported per the primary completion date (data cut-off date of 06Nov2020).

Participant milestones

Measure	Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Overall Study STARTED	40	104	75	69	84	47	3	5	6
Overall Study Treated	40	101	74	69	82	47	3	5	5
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	40	104	75	69	84	47	3	5	6

Reasons for withdrawal

Measure	Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Overall Study Death	31	74	47	54	63	18	2	5	5
Overall Study Withdrawal by Subject	4	7	4	3	3	2	0	0	1
Overall Study Lost to Follow-up	0	0	1	0	2	1	1	0	0
Overall Study Other	0	3	0	0	1	0	0	0	0
Overall Study Ongoing at the time of data cut-off date	5	20	23	12	15	26	0	0	0

Baseline Characteristics

A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Total n=433 Participants Total of all reporting groups
Race (NIH/OMB) Asian	19 Participants n=5 Participants	55 Participants n=7 Participants	44 Participants n=5 Participants	39 Participants n=4 Participants	47 Participants n=21 Participants	39 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	257 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	25 Participants n=42 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	35 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	30 Participants n=21 Participants	7 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	140 Participants n=42 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Age, Customized < 65 years	27 Participants n=5 Participants	52 Participants n=7 Participants	34 Participants n=5 Participants	41 Participants n=4 Participants	48 Participants n=21 Participants	26 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	241 Participants n=42 Participants
Age, Customized >=65 to < 75 years	8 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	18 Participants n=4 Participants	26 Participants n=21 Participants	13 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	130 Participants n=42 Participants
Age, Customized > 75 years	5 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	8 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	62 Participants n=42 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	14 Participants n=21 Participants	6 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	65 Participants n=42 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	92 Participants n=7 Participants	65 Participants n=5 Participants	57 Participants n=4 Participants	70 Participants n=21 Participants	41 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	368 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	21 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	99 Participants n=7 Participants	71 Participants n=5 Participants	65 Participants n=4 Participants	79 Participants n=21 Participants	47 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	6 Participants n=42 Participants	412 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 28 after first dose of study drug

Population: DLT evaluable set included all Part 1A participants who received at least 1 dose of study drug and completed the safety follow-up through the DLT evaluation period (Days 1 to 28 after first dose of study drug) or experienced any DLT.

A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any >= Grade 2 pneumonitis that does not resolve to <= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to <= Grade 1 or baseline within 14 days, liver transaminase elevation > 8 × upper limit of normal (ULN) or total bilirubin > 5 × ULN, aspartate aminotransferase or alanine aminotransferase > 3 × ULN with concurrent increase in total bilirubin > 2 × ULN without evidence of cholestasis or alternative explanations, and any >= Grade 3 non-irAE (except for the protocol stated conditions).

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=16 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Safety analysis set included all participants who received at least one dose of study drug.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=101 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=82 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=5 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TEAEs	38 Participants	95 Participants	73 Participants	67 Participants	80 Participants	45 Participants	3 Participants	5 Participants	5 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TESAEs	22 Participants	45 Participants	32 Participants	36 Participants	37 Participants	17 Participants	1 Participants	3 Participants	4 Participants

PRIMARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Safety analysis set included all participants who received at least one dose of study drug. 'Number of participants analyzed' denotes only those participants for whom hematological and clinical chemistry parameter were analyzed. 'Number Analyzed' denotes the participants analyzed for the specified laboratory parameter.

Participants with clinically important Common Terminology Criteria for Adverse Events (CTCAE) grade changes to 3 or 4 in hematology and chemistry parameters are reported. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=39 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=100 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=68 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=81 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=46 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=4 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Hemoglobin	0 Participants	5 Participants	6 Participants	6 Participants	6 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Leukocytes	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Lymphocytes	3 Participants	7 Participants	10 Participants	4 Participants	8 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Neutrophils	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Platelets	3 Participants	5 Participants	0 Participants	2 Participants	4 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Activated Partial Thromboplastin Time	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Fibrinogen	5 Participants	5 Participants	5 Participants	2 Participants	5 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Prothrombin Intl. Normalized Ratio	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Alanine Aminotransferase	3 Participants	7 Participants	13 Participants	5 Participants	10 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Albumin	1 Participants	5 Participants	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Alkaline Phosphatase	3 Participants	13 Participants	4 Participants	6 Participants	8 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Aspartate Aminotransferase	5 Participants	25 Participants	19 Participants	16 Participants	17 Participants	4 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Bilirubin	2 Participants	12 Participants	4 Participants	6 Participants	9 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Calcium - Hyper	0 Participants	4 Participants	0 Participants	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Calcium - Hypo	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Creatinine	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Glucose - Hyper	4 Participants	8 Participants	14 Participants	6 Participants	5 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Glucose - Hypo	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Magnesium - Hyper	2 Participants	7 Participants	3 Participants	2 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Magnesium - Hypo	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Potassium - Hyper	4 Participants	4 Participants	2 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Potassium - Hypo	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Sodium - Hyper	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters Sodium - Hypo	9 Participants	12 Participants	7 Participants	13 Participants	11 Participants	6 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Safety analysis set included all participants who received at least one dose of study drug.

Vital sign assessment included pulse rate, blood pressure, temperature, weight, and respiratory rate. Vital signs abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=101 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=82 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=5 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Abnormal Vital Signs Reported as TEAEs Hypertension	1 Participants	4 Participants	4 Participants	2 Participants	3 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Hypotension	0 Participants	4 Participants	0 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Systolic hypertension	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Weight decreased	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Weight increased	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Palpitations	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Pyrexia	6 Participants	6 Participants	14 Participants	9 Participants	14 Participants	4 Participants	2 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Safety analysis set included all participants who received at least one dose of study drug.

Number of participants with ECG abnormalities recorded as TEAEs are reported. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=101 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=82 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=5 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Angina unstable	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Cardiac arrest	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Acute myocardial infarction	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Angina pectoris	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Atrial fibrillation	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Cardiac failure chronic	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Cardiac failure congestive	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Coronary artery disease	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Sinus bradycardia	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Tachycardia	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Atrioventricular block first degree	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events Myocardial infarction	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

Disease assessments based on investigator assessments and BICR review were determined by using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) guidelines. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR). The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR) ORR based on BICR	—	11.5 Percentage of participants Interval 6.1 to 19.3	24.0 Percentage of participants Interval 14.9 to 35.3	7.2 Percentage of participants Interval 2.4 to 16.1	9.5 Percentage of participants Interval 4.2 to 17.9	21.3 Percentage of participants Interval 10.7 to 35.7	—	—	—
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR) ORR based on Investigator assessments	20.0 Percentage of participants Interval 9.1 to 35.6	11.5 Percentage of participants Interval 6.1 to 19.3	21.3 Percentage of participants Interval 12.7 to 32.3	8.7 Percentage of participants Interval 3.3 to 18.0	8.3 Percentage of participants Interval 3.4 to 16.4	34.0 Percentage of participants Interval 20.9 to 49.3	33.3 Percentage of participants Interval 0.8 to 90.6	NA Percentage of participants No participants reported a best overall response of CR or PR.	NA Percentage of participants No participants reported a best overall response of CR or PR.

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The DCR is defined as a BOR of confirmed CR, confirmed PR, or stable disease (SD). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Disease Control Rate (DCR) Based on Investigator Assessments and BICR DCR based on BICR	—	37.5 Percentage of participants	45.3 Percentage of participants	49.3 Percentage of participants	36.9 Percentage of participants	55.3 Percentage of participants	—	—	—
Disease Control Rate (DCR) Based on Investigator Assessments and BICR DCR based on Investigator assessments	60.0 Percentage of participants	45.2 Percentage of participants	50.7 Percentage of participants	47.8 Percentage of participants	34.5 Percentage of participants	63.8 Percentage of participants	33.3 Percentage of participants	20.0 Percentage of participants	16.7 Percentage of participants

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The TTR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.

Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTR is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR). A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=8 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=12 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=18 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=6 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=8 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=16 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=1 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Time to Response (TTR) Based on Investigator Assessments and BICR TTR based on BICR	—	3.65 Months Interval 2.71 to 5.59	2.28 Months Interval 1.81 to 3.68	1.81 Months Interval 1.81 to 1.84	2.86 Months Interval 1.84 to 3.83	2.10 Months Interval 1.87 to 4.11	—	—	—
Time to Response (TTR) Based on Investigator Assessments and BICR TTR based on Investigator assessments	2.68 Months Interval 1.82 to 4.6	3.68 Months Interval 1.81 to 5.55	1.86 Months Interval 1.77 to 5.59	2.74 Months Interval 1.81 to 5.32	3.88 Months Interval 1.81 to 5.32	2.10 Months Interval 1.94 to 4.12	5.55 Months Interval 5.55 to 5.55	—	—

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed. The DoR was analyzed for participants who achieved OR per BICR and/or investigator assessments. 'Number Analyzed' denotes participants who achieved OR.

The DoR is defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments and BICR review by using RECIST v1.1 or death in absence of disease progression. A confirmed CR is defined in above outcome measures. The PD is defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. The DoR was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=8 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=12 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=18 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=6 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=8 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=16 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=1 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Duration of Response (DoR) Based on Investigator Assessments and BICR DoR based on BICR	—	14.95 Months Interval 8.54 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	18.43 Months Interval 5.59 to 23.95	23.95 Months Interval 4.07 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	13.21 Months Interval 10.15 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 6.28 to Median and 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	—	—	—
Duration of Response (DoR) Based on Investigator Assessments and BICR DoR based on Investigator assessments	16.66 Months Interval 8.41 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	NA Months Interval 19.02 to Median and 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	23.95 Months Interval 5.59 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	27.53 Months Interval 27.53 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	13.21 Months Interval 12.85 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	10.51 Months Interval 10.51 to 75th percentile could not be derived due to insufficient events being observed at the time of the analysis.	7.39 Months Interval 7.39 to 7.39	—	—

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The TTP was defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 to the first documentation of radiographic disease progression. However, if the participant died without tumor progression, they were censored at the time of death. Participants with no documented PD by the data cutoff date for TTP analysis were censored at the date of their last evaluable disease assessment. The TTP was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Time to Progression (TTP) Based on Investigator Assessments and BICR TTP based on BICR	—	2.10 Months Interval 1.87 to 3.52	3.71 Months Interval 1.91 to 5.55	2.76 Months Interval 1.87 to 5.42	1.87 Months Interval 1.81 to 3.48	4.30 Months Interval 2.1 to 6.24	—	—	—
Time to Progression (TTP) Based on Investigator Assessments and BICR TTP based on Investigator assessments	3.68 Months Interval 2.23 to 6.77	3.38 Months Interval 2.0 to 4.67	3.68 Months Interval 2.07 to 5.52	2.60 Months Interval 1.87 to 5.29	1.87 Months Interval 1.77 to 3.48	7.46 Months Interval 4.01 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	1.81 Months Interval 1.64 to 12.91	3.75 Months Interval 1.81 to 3.75	2.68 Months Interval 1.84 to 3.48

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. Analysis of disease assessments based on BICR for Part 1 and China cohorts were not planned and hence not performed.

Disease assessments based on investigator assessments and BICR review were determined by using RECIST v1.1 guidelines. The PFS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until the first documentation of radiographic disease progression or death due to any cause, whichever occurs first. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared with the nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. Participants who were alive with no documented PD by the data cutoff date for PFS analysis were censored at the date of their last evaluable disease assessment. The PFS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Progression Free Survival (PFS) Based on Investigator Assessments and BICR PFS based on BICR	—	2.07 Months Interval 1.84 to 2.86	2.17 Months Interval 1.91 to 5.42	2.69 Months Interval 1.87 to 5.29	1.87 Months Interval 1.77 to 2.53	4.17 Months Interval 2.1 to 6.24	—	—	—
Progression Free Survival (PFS) Based on Investigator Assessments and BICR PFS based on Investigator assessments	3.52 Months Interval 1.87 to 5.29	2.40 Months Interval 1.91 to 3.65	3.52 Months Interval 2.07 to 5.42	2.60 Months Interval 1.87 to 3.71	1.81 Months Interval 1.77 to 2.4	6.24 Months Interval 3.94 to 12.55	1.81 Months Interval 1.64 to 12.91	2.20 Months Interval 1.81 to 3.75	1.87 Months Interval 0.66 to 3.48

SECONDARY outcome

Timeframe: From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Population: Full analysis set included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error.

The OS is defined as the time from randomization for Parts 2A and 3, and time from first dose for Parts 1, 2B, and 4 until death due to any cause. If there was no death reported for a participant by the data cut-off date for overall survival analysis, OS was censored at the last known alive date. The OS was estimated using Kaplan-Meier method. There will be no updated results for this outcome measure at the time of end of study.

Outcome measures

Measure	Part 1A: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 Participants Participants in Part 1A (safety run-in cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=104 Participants Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=75 Participants Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 Participants Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=84 Participants Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 Participants Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 Participants Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 Participants Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=6 Participants Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Overall Survival (OS)	12.58 Months Interval 6.87 to 20.99	12.91 Months Interval 8.74 to 16.79	17.05 Months Interval 10.55 to 22.83	17.05 Months Interval 11.33 to 20.24	11.30 Months Interval 8.38 to 14.95	NA Months Interval 12.52 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	30.69 Months Interval 13.96 to Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.	3.52 Months Interval 2.2 to 20.96	6.28 Months Interval 0.66 to 23.82

Adverse Events

Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg

Serious events: 22 serious events

Other events: 37 other events

Deaths: 31 deaths

Parts 2 and 3: Durvalumab 1500 mg

Serious events: 45 serious events

Other events: 92 other events

Deaths: 78 deaths

Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg

Serious events: 32 serious events

Other events: 73 other events

Deaths: 49 deaths

Parts 2 and 3: Tremelimumab 750 mg

Serious events: 36 serious events

Other events: 66 other events

Deaths: 55 deaths

Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg

Serious events: 37 serious events

Other events: 80 other events

Deaths: 64 deaths

Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg

Serious events: 17 serious events

Other events: 45 other events

Deaths: 18 deaths

China Cohort: Durvalumab 20 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

China Cohort: Tremelimumab 10 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 5 deaths

China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Measure	Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 participants at risk Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=101 participants at risk Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 participants at risk Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 participants at risk Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=82 participants at risk Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 participants at risk Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 participants at risk Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 participants at risk Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=5 participants at risk Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric varices	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhagic ascites	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestinal haemorrhage	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Mallory-weiss syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric haematoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal varices haemorrhage	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Varices oesophageal	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Asthenia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Death	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders General physical health deterioration	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Lipogranuloma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	2.5% 1/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Oedema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Autoimmune hepatitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Biliary obstruction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.9% 9/101 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Abdominal infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Anorectal infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	2.5% 1/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Covid-19	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Dengue fever	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Encephalitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Klebsiella infection	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Listeria sepsis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Listeriosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Liver abscess	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Meningitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Peritonitis bacterial	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Rhinovirus infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Tuberculosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Urosepsis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Ammonia increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Lipase increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic metabolic decompensation	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liver carcinoma ruptured	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Cauda equina syndrome	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour rupture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Depressed level of consciousness	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhagic stroke	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hyperammonaemic encephalopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Myasthenia gravis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Seizure	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Spinal cord compression	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety disorder	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Mental status changes	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Suicide attempt	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hypophysitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Angina unstable	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Myocarditis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hypopituitarism	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Ascites	5.0% 2/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Autoimmune colitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Autoimmune pancreatitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Lymphoedema	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Shock haemorrhagic	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.

Other adverse events

Measure	Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=40 participants at risk Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) received tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Durvalumab 1500 mg n=101 participants at risk Participants received durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg n=74 participants at risk Participants received tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 750 mg n=69 participants at risk Participants received tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg n=82 participants at risk Participants received tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg n=47 participants at risk Participants received durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Durvalumab 20 mg/kg n=3 participants at risk Participants received durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 10 mg/kg n=5 participants at risk Participants received tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.	China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg n=5 participants at risk Participants received tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Cardiac disorders Palpitations	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Adrenal insufficiency	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hyperthyroidism	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.1% 6/74 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Retinal tear	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hypopituitarism	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Hypothyroidism	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.9% 12/101 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.8% 8/74 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.8% 8/82 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 4/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Immune-mediated endocrinopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Endocrine disorders Thyroiditis	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Cataract	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Conjunctivitis allergic	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Dry eye	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 3/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Eyelid ptosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Eyelids pruritus	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Glaucoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Meibomian gland dysfunction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Photopsia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Vision blurred	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Visual impairment	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Eye disorders Vitreous floaters	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.9% 10/101 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.8% 8/74 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.1% 5/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal hernia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal mass	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	17.5% 7/40 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.9% 15/101 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.5% 10/74 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	21.7% 15/69 • Number of events 19 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.4% 11/82 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.9% 7/47 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.0% 2/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Anal incontinence	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Anorectal swelling	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Ascites	15.0% 6/40 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.9% 8/101 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.5% 10/74 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	15.0% 6/40 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.9% 12/101 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.8% 8/74 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.1% 7/69 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.2% 10/82 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	35.0% 14/40 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	16.8% 17/101 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	18.9% 14/74 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	27.5% 19/69 • Number of events 29 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	17.1% 14/82 • Number of events 23 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	19.1% 9/47 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.1% 5/82 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Hypoacusis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain lower	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal varices	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysbiosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyschezia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.1% 6/74 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Food poisoning	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric varices	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal pain	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Glossitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Melaena	2.5% 1/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	15.0% 6/40 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.9% 12/101 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.5% 10/74 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.3% 14/69 • Number of events 15 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.4% 11/82 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Peptic ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Pigmentation lip	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Portal hypertensive gastropathy	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Proctalgia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Toothache	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Varices oesophageal	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	15.0% 6/40 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.8% 8/82 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Adverse drug reaction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Asthenia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 3/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Catheter site pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Chest pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Chills	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Face oedema	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Fatigue	32.5% 13/40 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	22.8% 23/101 • Number of events 28 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	23.0% 17/74 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	27.5% 19/69 • Number of events 22 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	18.3% 15/82 • Number of events 19 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	21.3% 10/47 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Gait disturbance	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Generalised oedema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Hyperthermia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Influenza like illness	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Infusion site reaction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Injection site erythema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Localised oedema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Malaise	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Mucosal hyperaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Mucosal inflammation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Oedema	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Oedema peripheral	10.0% 4/40 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.9% 15/101 • Number of events 15 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	16.2% 12/74 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.6% 12/82 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 4/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Peripheral swelling	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Puncture site pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Pyrexia	12.5% 5/40 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.9% 11/74 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.0% 9/69 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.4% 11/82 • Number of events 15 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Swelling	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Swelling face	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Thirst	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
General disorders Xerosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatomegaly	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatorenal syndrome	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Hypertransaminasaemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Immune system disorders Anaphylactic shock	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Immune system disorders Contrast media allergy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Candida infection	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile infection	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Conjunctivitis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Cystitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Device related infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Ear infection	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Enterococcal bacteraemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Escherichia infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Folliculitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Fungal infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Fungal skin infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Furuncle	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis salmonella	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Gastrointestinal candidiasis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Gingivitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Hepatitis b	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Herpes simplex	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Hordeolum	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Influenza	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Liver abscess	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Myringitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Onychomycosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Paronychia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Parotitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Peritonitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Peritonitis bacterial	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Pyuria	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Rash pustular	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Rhinitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Scrotal cellulitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Scrotal infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Skin bacterial infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Tinea pedis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Tonsillitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	10.0% 4/40 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.6% 8/69 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Urethritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.9% 7/101 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Vaginal infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Infections and infestations Viral infection	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Acquired pigmented retinopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post embolisation syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pain	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Radiation skin injury	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin wound	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	22.5% 9/40 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	22.8% 23/101 • Number of events 33 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	23.0% 17/74 • Number of events 28 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	15.9% 11/69 • Number of events 19 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	18.3% 15/82 • Number of events 19 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	100.0% 3/3 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Ammonia increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.9% 11/101 • Number of events 18 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.1% 7/69 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Amylase increased	10.0% 4/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.9% 8/101 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	16.2% 12/74 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.6% 8/69 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.8% 8/82 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	22.5% 9/40 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	25.7% 26/101 • Number of events 33 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	31.1% 23/74 • Number of events 38 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	27.5% 19/69 • Number of events 29 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	25.6% 21/82 • Number of events 27 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.8% 6/47 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	100.0% 3/3 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Bilirubin conjugated increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood albumin decreased	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood uric acid increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.9% 10/101 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.5% 10/69 • Number of events 16 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 7/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood cholesterol increased	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood creatine increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood glucose increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood magnesium decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood potassium decreased	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood pressure increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood pressure systolic increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood sodium decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations C-reactive protein increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Ejection fraction decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.8% 5/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Granulocyte count decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Heart rate decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Hepatitis b dna increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations International normalised ratio increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Lipase increased	17.5% 7/40 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	16.2% 12/74 • Number of events 20 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.3% 14/69 • Number of events 30 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Liver function test increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Low density lipoprotein increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	2.5% 1/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 3/69 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Platelet count decreased	5.0% 2/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Protein urine present	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Thyroid function test abnormal	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Thyroxine increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Transaminases increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Tri-iodothyronine increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Weight decreased	12.5% 5/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations Weight increased	5.0% 2/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Investigations White blood cell count increased	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	17.5% 7/40 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.9% 14/101 • Number of events 15 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.5% 10/74 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	23.2% 16/69 • Number of events 16 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	17.1% 14/82 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	25.5% 12/47 • Number of events 14 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Electrolyte imbalance	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Glucose tolerance impaired	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperalbuminaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.9% 8/101 • Number of events 11 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.1% 5/82 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 3/69 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	7.5% 3/40 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.9% 7/101 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoferritinaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	5.0% 2/40 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.8% 5/74 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 3/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.1% 5/82 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	17.5% 7/40 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.9% 8/101 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.8% 8/74 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	13.0% 9/69 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 7/82 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	17.5% 7/40 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.9% 15/101 • Number of events 16 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.8% 6/47 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone erosion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Depressed level of consciousness	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 4/40 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.9% 4/82 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal papilloma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Bloody discharge	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour thrombosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Amnesia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Balance disorder	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Disturbance in attention	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	10.0% 4/40 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Dizziness postural	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Dysarthria	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.6% 8/69 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hemiparesis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Hypokinesia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Lacunar infarction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Lethargy	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Memory impairment	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Metabolic encephalopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Monoparesis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Myelopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Sciatica	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Somnolence	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Taste disorder	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Nervous system disorders Tremor	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Affect lability	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Agitation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	15.0% 6/40 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.9% 7/101 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.6% 8/69 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Irritability	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Mood altered	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Psychiatric disorders Restlessness	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Azotaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Dysuria	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Hypertonic bladder	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Micturition urgency	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Nocturia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	23.4% 11/47 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Renal injury	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Genital erythema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Gynaecomastia	2.5% 1/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Nipple pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Oedema genital	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Penile pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Penile rash	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Testicular pain	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Choking sensation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 5/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.9% 12/101 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.3% 15/74 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	15.9% 11/69 • Number of events 17 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	18.3% 15/82 • Number of events 18 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 4/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 4/47 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 8/40 • Number of events 8 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.9% 10/101 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.8% 6/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.7% 6/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	7.5% 3/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory symptom	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.2% 5/69 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Lichen planus	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Macule	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	5.0% 2/40 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Papule	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	27.5% 11/40 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	19.8% 20/101 • Number of events 26 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	39.2% 29/74 • Number of events 42 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.6% 28/69 • Number of events 38 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	25.6% 21/82 • Number of events 25 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	8.5% 4/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Purpura senile	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	12.5% 5/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.9% 13/101 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	36.5% 27/74 • Number of events 33 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	29.0% 20/69 • Number of events 27 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	17.1% 14/82 • Number of events 15 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	10.6% 5/47 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.6% 8/69 • Number of events 10 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	7.3% 6/82 • Number of events 7 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Embolism	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.1% 3/74 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Flushing	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticarial vasculitis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	5.0% 2/40 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	9.5% 7/74 • Number of events 12 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	14.5% 10/69 • Number of events 13 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	11.0% 9/82 • Number of events 16 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.3% 2/47 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/69 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.7% 2/74 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 2/40 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.8% 4/69 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	6.4% 3/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.2% 1/82 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.1% 1/47 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block first degree	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Hypertension	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	5.4% 4/74 • Number of events 5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	3.7% 3/82 • Number of events 9 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	12.8% 6/47 • Number of events 6 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Haematoma	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Hyperaemia	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 4 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.9% 2/69 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	2.4% 2/82 • Number of events 2 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Inferior vena caval occlusion	2.5% 1/40 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Intermittent claudication	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Systolic hypertension	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/74 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Vena cava thrombosis	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.00% 0/40 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/101 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	1.4% 1/74 • Number of events 1 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/69 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/82 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/47 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/3 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.	0.00% 0/5 • From Day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) All-Cause Mortality was evaluated per 'Full analysis set' which included all randomized participants (Parts 2A and 3) or participants who were allocated to treatment (Parts 1, 2B, and 4), including participants who were randomized in error. The AE data was evaluated per 'Safety population' which included all participants who received at least one dose of study drug.

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
• Publication restrictions are in place

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