Trial Outcomes & Findings for A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 (NCT NCT04470427)

NCT ID: NCT04470427

Last Updated: 2024-03-21

Results Overview

COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19. An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30415 participants
• Primary outcome timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose
• Results posted on: 2024-03-21

Participant Flow

Part A participants received mRNA-1273, or placebo. After completion of Part A, participants could have chosen to be unblinded so that participants who received placebo in Part A could request to receive open-label mRNA-1273 in Part B. Eligible participants who received at least one dose of mRNA-1273 in the study had the option to receive a booster dose of mRNA-1273 in Part C.

Participant milestones

Measure	Part A (Blinded): Placebo Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.	Part C: mRNA-1273 Booster Participants received 50 μg mRNA-1273 booster.
Part A: Blinded STARTED	15206	15209	0	0	0	0
Part A: Blinded Received Any Study Injection	15166	15180	0	0	0	0
Part A: Blinded Per-Protocol (PP) Set:	14164	14287	0	0	0	0
Part A: Blinded Per-Protocol Random Subcohort for Immunogenicity (PPRSI)	272	1185	0	0	0	0
Part A: Blinded Solicited Safety Set	15159	15179	0	0	0	0
Part A: Blinded Safety Set	15162	15184	0	0	0	0
Part A: Blinded Full Analysis Set	15166	15180	0	0	0	0
Part A: Blinded COMPLETED	14375	14661	0	0	0	0
Part A: Blinded NOT COMPLETED	831	548	0	0	0	0
Part B :Open-label STARTED	0	0	2513	12649	15184	0
Part B :Open-label Safety Set	0	0	2513	12649	15184	0
Part B :Open-label PP Set	0	0	2104	12060	14287	0
Part B :Open-label Participants Who Had PDV/Unblinding) and Had the Option to Receive Booster Dose in Part C	0	0	1725	12649	14661	0
Part B :Open-label COMPLETED	0	0	149	10464	10171	0
Part B :Open-label NOT COMPLETED	0	0	2364	2185	5013	0
Part C: Booster STARTED	0	0	0	0	0	19609
Part C: Booster PP Set	0	0	0	0	0	16368
Part C: Booster PP Immunogenicity Subset (PPIS)	0	0	0	0	0	731
Part C: Booster PPIS-Negative (Neg)	0	0	0	0	0	682
Part C: Booster COMPLETED	0	0	0	0	0	16691
Part C: Booster NOT COMPLETED	0	0	0	0	0	2918

Reasons for withdrawal

Measure	Part A (Blinded): Placebo Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.	Part C: mRNA-1273 Booster Participants received 50 μg mRNA-1273 booster.
Part A: Blinded Discontinued from Study in Part A	831	548	0	0	0	0
Part B :Open-label Other than specified	0	0	788	0	523	0
Part B :Open-label Discontinued from Study in Part B	0	0	1576	2185	4490	0
Part C: Booster Discontinued from Study in Part C	0	0	0	0	0	2918

Baseline Characteristics

A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

Baseline characteristics by cohort

Measure	Placebo n=15166 Participants Participants randomized to mRNA-1273-matching placebo and received any study injection in Part A.	mRNA-1273 n=15180 Participants Participants randomized to mRNA-1273 and received any study injection in Part A.	Total n=30346 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 15.60 • n=5 Participants	51.4 years STANDARD_DEVIATION 15.50 • n=7 Participants	51.4 years STANDARD_DEVIATION 15.55 • n=5 Participants
Sex: Female, Male Female	7109 Participants n=5 Participants	7263 Participants n=7 Participants	14372 Participants n=5 Participants
Sex: Female, Male Male	8057 Participants n=5 Participants	7917 Participants n=7 Participants	15974 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3109 Participants n=5 Participants	3121 Participants n=7 Participants	6230 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11921 Participants n=5 Participants	11917 Participants n=7 Participants	23838 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	136 Participants n=5 Participants	142 Participants n=7 Participants	278 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	12001 Participants n=5 Participants	12031 Participants n=7 Participants	24032 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1531 Participants n=5 Participants	1567 Participants n=7 Participants	3098 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	739 Participants n=5 Participants	656 Participants n=7 Participants	1395 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	121 Participants n=5 Participants	113 Participants n=7 Participants	234 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiracial	319 Participants n=5 Participants	319 Participants n=7 Participants	638 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	294 Participants n=5 Participants	299 Participants n=7 Participants	593 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	74 Participants n=5 Participants	97 Participants n=7 Participants	171 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	55 Participants n=5 Participants	62 Participants n=7 Participants	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

Population: Part A PP Set. Number analyzed=participants evaluable at specified timepoint.

COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.

An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose	744 Participants	55 Participants	—	—	—

PRIMARY outcome

Timeframe: up to Day 7 (7 days after first dose)

Population: Solicited Safety Set: All randomized participants who received at least 1 dose and contributed any solicited AR data; (had at least 1 post-baseline solicited safety assessment. Participants were included in the treatment group corresponding to the study vaccination they actually received. Number analyzed=participants evaluable at specified timepoint.

Solicited ARs (local and systemic) were collected in electronic diary (eDiary) within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; a lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

Outcome measures

Measure	Part A (Blinded): Placebo n=15151 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15166 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose Grade 1	5134 Participants	9329 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose Grade 2	1782 Participants	3134 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose Grade 3	363 Participants	849 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After First Dose Grade 4	6 Participants	5 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 29 to Day 35 (from second dose to 7 days after second dose)

Population: Solicited Safety Set: Randomized participants who received at least 1 dose and contributed any solicited AR data. Participants were included in the treatment group corresponding to the study vaccination they actually received. Number analyzed=participants evaluable at specified timepoint. No solicited ARs were collected in Part B because sufficient data had already been captured and analyzed in Part A.

Solicited ARs (local and systemic) were collected in eDiary within 7 days of dosing. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Severity grading for solicited ARs is based on modified Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials. Severity was graded 0-4; lower score indicated lower severity and a higher score indicated greater severity. The Investigator determined if solicited AR was also to be recorded as an AE. Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section

Outcome measures

Measure	Part A (Blinded): Placebo n=14578 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14691 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose Grade 1	4346 Participants	4847 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose Grade 2	1558 Participants	5800 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose Grade 3	348 Participants	2895 Participants	—	—	—
Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) After Second Dose Grade 4	3 Participants	14 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 (after dosing) through end of study (up to Day 759)

Population: Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.

An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Outcome measures

Measure	Part A (Blinded): Placebo n=15162 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15184 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2513 Participants Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12649 Participants Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=15184 Participants Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation MAAEs	4561 Participants	3921 Participants	109 Participants	5513 Participants	5809 Participants
Parts A and B: Number of Participants With Medically Attended AEs (MAAEs) and AEs Leading to Discontinuation AEs Leading to Discontinuation	25 Participants	27 Participants	3 Participants	30 Participants	35 Participants

PRIMARY outcome

Timeframe: Day 1 (after dosing) through end of study (up to Day 759)

Population: Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.

An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

Outcome measures

Measure	Part A (Blinded): Placebo n=15162 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15184 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2513 Participants Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12649 Participants Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=15184 Participants Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Parts A and B: Number of Participants With Serious AEs (SAEs)	308 Participants	292 Participants	15 Participants	536 Participants	516 Participants

SECONDARY outcome

Timeframe: Up to 28 days after any dose

Population: Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set.

Unsolicited AE was any AE reported by the participant that was not specified as an AR or was specified as a solicited AR in the protocol but started outside the protocol-defined, post-injection period for reporting solicited ARs. Unsolicited AEs were collected for the 28 days after any injection.

An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.

Outcome measures

Measure	Part A (Blinded): Placebo n=15162 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15184 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose	4338 Participants	4752 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B

Population: Parts A and B PP Sets. Number analyzed=participants evaluable at specified timepoint.

COVID-19 cases were defined as participants meeting clinical criteria based on symptoms for COVID-19 and reverse transcriptase polymerase chain reaction (RT-PCR) detection of SARS-CoV-2 from samples collected within 72 hours of the participant reporting symptoms meeting the definition of COVID-19.

An adjudication committee reviewed potential cases to determine if the criteria for COVID-19 were met.

Clinical signs indicative of severe COVID-19 systemic illness included any of the following: respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, oxygen saturation (SpO2) ≤93% on room air at sea level, or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FIO2) <300 millimeter of mercury (mm Hg), or respiratory failure or acute respiratory distress syndrome (ARDS), evidence of shock, or significant acute renal, hepatic, or neurologic dysfunction, or admission to an intensive care unit or death.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2104 Participants Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12060 Participants Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=14287 Participants Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Parts A and B: Number of Participants With a First Occurrence of Severe COVID-19 Starting 14 Days After Second Dose	106 Participants	2 Participants	1 Participants	8 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

Population: Part A PP Set. Number analyzed=participants evaluable at specified timepoint.

COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.

An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.

SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection Regardless of Symptomatology or Severity Starting 14 Days After Second Dose	1339 Participants	280 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

Population: Part A PP Set. Number analyzed=participants evaluable at specified timepoint.

Secondary case definition of COVID-19 was defined as the presence of at least 1 of the following systemic symptoms: fever (temperature

≥38ºC), or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea and a positive nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) for SARS-CoV-2 by RT-PCR.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a Secondary Case Definition of COVID-19 Starting 14 Days After Second Dose	807 Participants	58 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 8 months for Part A and from PDV/unblinding (at 4 months) to up to 8 months for Part B

Population: Parts A and B PP Set. Number analyzed=participants evaluable at specified timepoint.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2104 Participants Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12060 Participants Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=14287 Participants Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Parts A and B: Number of Participants Who Died Due to a Cause Directly Attributed to a Complication of COVID-19 Starting 14 Days After Second Dose	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 14 days after first dose up to approximately 8 months

Population: Part A PP Set. Number analyzed=participants evaluable at specified timepoint.

COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.

An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After First Dose	769 Participants	56 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

Population: Part A FAS. Number analyzed=participants evaluable at specified timepoint.

COVID-19 cases were defined as participants meeting clinical criteria based both on symptoms for COVID-19 and on RT-PCR detection of SARS-CoV-2 from samples collected within 72 hours of the study participant reporting symptoms that met the definition of COVID-19.

An adjudication committee was assembled for the purpose of reviewing potential cases to determine if the criteria for COVID-19 were met.

Outcome measures

Measure	Part A (Blinded): Placebo n=15166 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15180 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a First Occurrence of COVID-19 Starting 14 Days After Second Dose Regardless of Evidence of Prior SARS-CoV-2 Infection	754 Participants	58 Participants	—	—	—

SECONDARY outcome

Timeframe: From Day 43 (14 days after second dose) up to approximately 7 months after the second dose

Population: Part A PP Set. Number analyzed=participants evaluable at specified timepoint.

SARS-CoV-2 infection was defined by seroconversion due to infection measured by binding antibody (bAb) levels against SARS-CoV-2 nucleocapsid or by positive RT-PCR at predefined timepoints. Seroconversion was defined by the participant's serostatus at baseline.

Outcome measures

Measure	Part A (Blinded): Placebo n=14164 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=14287 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Number of Participants With a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 Days After Second Dose	498 Participants	214 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 29, Day 57

Population: Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.

GMT (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported.

95% CI was based on the t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation.

Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.

Outcome measures

Measure	Part A (Blinded): Placebo n=272 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=1185 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative, ID50, Day 1	NA Titer All antibody values were below the lower limit of quantification (LLOQ), therefore, no data for assessment.	9.624 Titer Interval 9.35 to 9.9	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative', ID50, Day 29	9.515 Titer Interval 9.0 to 10.06	54.866 Titer Interval 50.98 to 59.04	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative', ID50, Day 57	9.903 Titer Interval 8.99 to 10.9	1081.124 Titer Interval 1019.8 to 1146.14	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative', ID80, Day 1	NA Titer All antibody values were below LLOQ, therefore, no data for assessment.	7.332 Titer Interval 7.18 to 7.49	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative', ID80, Day 29	7.279 Titer Interval 7.03 to 7.54	19.684 Titer Interval 18.55 to 20.89	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Negative', ID80, Day 57	7.522 Titer Interval 7.0 to 8.09	334.867 Titer Interval 317.84 to 352.81	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID50, Day 1	82.519 Titer Interval 59.4 to 114.64	68.117 Titer Interval 49.88 to 93.02	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID50, Day 29	52.728 Titer Interval 39.45 to 70.48	1478.910 Titer Interval 1069.6 to 2044.86	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID50, Day 57	47.708 Titer Interval 35.41 to 64.28	3145.904 Titer Interval 2539.8 to 3896.66	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID80, Day 1	29.580 Titer Interval 22.39 to 39.09	24.996 Titer Interval 19.12 to 32.68	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID80, Day 29	20.994 Titer Interval 16.42 to 26.84	518.388 Titer Interval 380.39 to 706.44	—	—	—
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Baseline SARS-CoV-2 Positive, ID80, Day 57	19.228 Titer Interval 15.03 to 24.6	1099.847 Titer Interval 903.83 to 1338.37	—	—	—

SECONDARY outcome

Timeframe: Day 29, Day 57

Population: Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.

The GMFR measures the changes in immunogenicity titers or levels from Baseline within participants.

95% CI was calculated based on the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. GMFR for ID50 and ID80 neutralizing antibodies against SARS-CoV-2 S-protein, as measured by pseudovirus neutralizing antibody is presented. Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1

Outcome measures

Measure	Part A (Blinded): Placebo n=271 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=1182 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Negative, ID50 Day 29	1.03 Ratio Interval 0.97 to 1.09	5.69 Ratio Interval 5.29 to 6.12	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Negative, ID50 Day 57	1.07 Ratio Interval 0.97 to 1.18	112.30 Ratio Interval 105.42 to 119.62	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2, Negative, ID80 Day 29	1.02 Ratio Interval 0.98 to 1.05	2.68 Ratio Interval 2.53 to 2.84	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Negative, ID80 Day 57	1.05 Ratio Interval 0.98 to 1.13	45.62 Ratio Interval 43.21 to 48.17	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2, Positive, ID50 Day 29	0.64 Ratio Interval 0.56 to 0.73	21.71 Ratio Interval 16.08 to 29.32	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Positive, ID50 Day 57	0.59 Ratio Interval 0.5 to 0.69	46.18 Ratio Interval 34.1 to 62.55	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Positive, ID80 Day 29	0.71 Ratio Interval 0.64 to 0.79	20.74 Ratio Interval 15.3 to 28.1	—	—	—
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Baseline SARS-CoV-2 Positive, ID80 Day 57	0.66 Ratio Interval 0.57 to 0.75	44.00 Ratio Interval 33.99 to 56.97	—	—	—

SECONDARY outcome

Timeframe: Day 29, Day 57

Population: Part A PPRSI Set. Number analyzed=participants evaluable at specified timepoint. Immunogenicity samples from the Part B were not tested and no data were generated as results were not thought to provide additional information.

Seroresponse to pseudovirus neutralizing antibody ID50 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 3.3-fold rise if baseline is equal to or above the LLOQ. Seroresponse to pseudovirus neutralizing antibody ID80 titer at a participant level is defined as a change from below the LLOQ to equal or above the LLOQ, or at least a 2.3-fold rise if baseline is equal to or above the LLOQ.

Baseline SARS-CoV-2 Status: Positive if there is immunologic or virologic evidence of prior COVID-19, defined as positive RT-PCR test or positive Elecsys result at Day 1. Negative is defined as negative RT-PCR test and negative Elecsys result at Day 1.

Outcome measures

Measure	Part A (Blinded): Placebo n=272 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=1185 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Negative, ID50, Day 29	0.7 percentage of participants Interval 0.0 to 3.9	81.4 percentage of participants Interval 78.9 to 83.7	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Negative, ID50, Day 57	1.4 percentage of participants Interval 0.2 to 5.0	98.9 percentage of participants Interval 98.0 to 99.4	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Negative, ID80, Day 29	0.7 percentage of participants Interval 0.0 to 3.9	63.0 percentage of participants Interval 60.0 to 65.9	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Negative, ID80, Day 57	1.4 percentage of participants Interval 0.2 to 5.0	98.9 percentage of participants Interval 98.0 to 99.4	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Positive, ID50, Day 29	0.8 percentage of participants Interval 0.0 to 4.3	87.7 percentage of participants Interval 80.8 to 92.8	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Positive, ID50, Day 57	1.6 percentage of participants Interval 0.2 to 5.5	94.6 percentage of participants Interval 89.2 to 97.8	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Positive, ID80, Day 29	3.1 percentage of participants Interval 0.9 to 7.8	90.0 percentage of participants Interval 83.5 to 94.6	—	—	—
Part A: Percentage of Participants With Seroresponse Against SARS-CoV-2 Baseline SARS-CoV-2 Positive, ID80, Day 57	2.3 percentage of participants Interval 0.5 to 6.6	96.2 percentage of participants Interval 91.3 to 98.7	—	—	—

SECONDARY outcome

Timeframe: Pre-booster (Baseline), post-booster Day 29 and post-booster Day 181

Population: Part C PPIS Set. Number analyzed=participants evaluable at specified timepoint.

95% CI is calculated based on the t-distribution of the log-transformed values for GM value, then back transformed to the original scale for presentation.

Outcome measures

Measure	Part A (Blinded): Placebo n=700 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62) Pre-booster (Baseline)	163.848 Titer Interval 147.977 to 181.421	—	—	—	—
Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62) BD Day 29	8122.189 Titer Interval 7603.021 to 8676.808	—	—	—	—
Part C: GMT of SARS-CoV-2 Specific nAb Measured by Pseudovirus (VAC62) BD Day 181	2951.123 Titer Interval 2701.648 to 3223.636	—	—	—	—

SECONDARY outcome

Timeframe: Post-booster Day 29 and post-booster Day 181

Population: Part C PPIS Set. Number analyzed=participants evaluable at specified timepoint.

Pseudovirus neutralizing antibody (VAC62) from pre-booster is presented. Seroresponse at a participant level is defined as a change from below the LLOQ to >= 4 x LLOQ, or at least a 4-fold rise if pre-booster is equal to or above the LLOQ.

Outcome measures

Measure	Part A (Blinded): Placebo n=670 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62) BD Day 29	94.5 percentage of participants Interval 92.5 to 96.1	—	—	—	—
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 Measured by Pseudovirus (VAC62) BD Day 181	89.2 percentage of participants Interval 86.4 to 91.6	—	—	—	—

SECONDARY outcome

Timeframe: Part C BD Day 29 and Part A Day 57

Population: Part C PPIS Set pre-booster SARS-CoV-2 negative. Number analyzed=participants evaluable at specified timepoint.

95% CI is calculated based on the t-distribution of the log-transformed values for GMC, then back transformed to the original scale for presentation.

Outcome measures

Measure	Part A (Blinded): Placebo n=636 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=680 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62) Part C BD Day 29	7739.680 arbitrary units (AU)/milliliters (mL) Interval 7240.926 to 8272.789	—	—	—	—
Part C: Geometric Mean Concentration (GMC) of SARS-CoV-2 Specific nAb After BD Compared to After Second Dose in Part A Measured by Pseudovirus (VAC62) Part A Day 57	—	1111.274 arbitrary units (AU)/milliliters (mL) Interval 1041.684 to 1185.513	—	—	—

SECONDARY outcome

Timeframe: Part C BD Day 29 and Part A Day 57

Population: Part C PPIS Set pre-booster SARS-CoV-2 negative. Number analyzed=participants evaluable at specified timepoint.

Pseudovirus neutralizing antibody (VAC62) are presented. Seroresponse at a participant level is defined as a change from below the LLOQ to equal or above 4 x LLOQ, or at least a4-fold rise if baseline (Pre- Dose 1) is equal to or above the LLOQ.

Outcome measures

Measure	Part A (Blinded): Placebo n=636 Participants Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=680 Participants Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A Part C BD Day 29	100 percentage of participants Interval 99.4 to 100.0	—	—	—	—
Part C: Percentage of Participants With Seroresponse Against SARS-CoV-2 After BD Compared to After Second Dose in Part A Part A Day 57	—	98.8 percentage of participants Interval 97.7 to 99.5	—	—	—

Adverse Events

Part A (Blinded): Placebo

Serious events: 308 serious events

Other events: 2783 other events

Deaths: 18 deaths

Part A (Blinded): mRNA-1273

Serious events: 292 serious events

Other events: 2247 other events

Deaths: 16 deaths

Part B (Open-label): Placebo

Serious events: 15 serious events

Other events: 42 other events

Deaths: 2 deaths

Part B (Open-label): Placebo/mRNA-1273

Serious events: 536 serious events

Other events: 1739 other events

Deaths: 23 deaths

Part B (Open-label): mRNA-1273

Serious events: 516 serious events

Other events: 1404 other events

Deaths: 35 deaths

Part C: mRNA-1273 Booster

Serious events: 755 serious events

Other events: 8277 other events

Deaths: 52 deaths

Serious adverse events

Measure	Part A (Blinded): Placebo n=15162 participants at risk Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15184 participants at risk Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2513 participants at risk Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12649 participants at risk Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=15184 participants at risk Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.	Part C: mRNA-1273 Booster n=19609 participants at risk Participants received 50 μg mRNA-1273 booster.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Abdominal abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Abscess intestinal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Abscess limb	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Acute sinusitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Anal abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Appendiceal abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Appendicitis	0.03% 5/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.10% 13/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 7/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 13/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Appendicitis perforated	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Arthritis bacterial	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Arthritis gonococcal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Arthritis infective	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Bacteraemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Bacterial infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Bacterial sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Biliary sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Breast abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Breast cellulitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Bronchitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations COVID-19	0.22% 33/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 2/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 10/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 8/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations COVID-19 pneumonia	0.07% 10/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Campylobacter sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Cellulitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 9/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 8/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Cellulitis staphylococcal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Cholecystitis infective	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Clostridium bacteraemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Clostridium difficile colitis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Clostridium difficile infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Coccidioidomycosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Colonic abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Cystitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Device related infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Diabetic foot infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Diverticulitis	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 12/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Empyema	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Enterobacter sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Enterococcal bacteraemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Epididymitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Escherichia infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Escherichia urinary tract infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Extradural abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Fournier's gangrene	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gangrene	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastroenteritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastroenteritis norovirus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastroenteritis viral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastrointestinal candidiasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Gastrointestinal infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Giardiasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Groin abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Haematoma infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Helicobacter infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Hepatitis A	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Herpes simplex meningitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Implant site infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Infected bite	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Influenza	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Intervertebral discitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Joint abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Klebsiella sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Liver abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Localised infection	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Lung abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Mastoiditis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Medical device site infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Meningitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Meningitis aseptic	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Oesophageal candidiasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Orchitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Osteomyelitis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Osteomyelitis acute	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Osteomyelitis bacterial	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Osteomyelitis chronic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Otitis media acute	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pericarditis infective	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Perineal abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Periorbital cellulitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Perirectal abscess	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Peritoneal abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Peritonitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Peritonitis bacterial	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pharyngitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pharyngitis streptococcal	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pilonidal cyst	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia	0.07% 11/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 9/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.20% 25/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 13/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.10% 19/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia bacterial	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia klebsiella	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Postoperative abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia pseudomonal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia staphylococcal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pneumonia streptococcal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Post procedural cellulitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Post procedural infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Postoperative wound infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pyelonephritis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Pyelonephritis acute	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Rhinovirus infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Salpingitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Sepsis	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.13% 16/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 9/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Septic encephalopathy	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Septic shock	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Shigella infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Shigella sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Sialoadenitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Sinusitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Spinal cord abscess	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Spinal cord infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Staphylococcal infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Staphylococcal sepsis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Streptococcal endocarditis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Streptococcal infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Streptococcal sepsis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Subcutaneous abscess	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Suspected COVID-19	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Tonsillitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Tooth abscess	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Toxic shock syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Upper respiratory tract infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Urinary tract infection	0.03% 5/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 8/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 13/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Urinary tract infection bacterial	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Urosepsis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Viral infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Viral pharyngitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Wound infection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large-cell lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Ventricular arrhythmia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Ventricular extrasystoles	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thymus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Ventricular fibrillation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline mucinous tumour of ovary	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer male	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Ventricular tachycardia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-cell lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic aneurysm	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ewing's sarcoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage III	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Drug abuse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-grade B-cell lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hormone receptor positive breast cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic aneurysm rupture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Langerhans' cell histiocytosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage I	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage II	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage III	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of thymus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myxofibrosarcoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma benign	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic dissection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian clear cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic neoplasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic malignant fibrous histiocytoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolactin-producing pituitary tumour	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 8/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 8/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Aortic stenosis	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer stage IV	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic marginal zone lymphoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell type acute leukaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma malignant	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer metastatic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Anaemia	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 6/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Anaemia macrocytic	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Blood loss anaemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Iron deficiency anaemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Pernicious anaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Thrombocytopenia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Blood and lymphatic system disorders Thrombocytosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Allergy to arthropod sting	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Anaphylactic reaction	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Anaphylactic shock	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Cytokine storm	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Immune system disorders Drug hypersensitivity	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Basedow's disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Goitre	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Hyperthyroidism	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Dehydration	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Diabetic complication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Euglycaemic diabetic ketoacidosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Fluid overload	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Gout	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Arterial haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypoglycaemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypokalaemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hypomagnesaemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Hyponatraemia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Obesity	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Pseudohyponatraemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Acute stress disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Agitation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Alcohol abuse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Alcohol use disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Alcohol withdrawal syndrome	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Alcoholism	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Anxiety	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Anxiety disorder	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Bipolar I disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Bipolar disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Catatonia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Completed suicide	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Confusional state	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Delirium	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Depression	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 7/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Depression suicidal	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Drug dependence	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Intentional self-injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Major depression	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Mania	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Mental status changes	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Panic attack	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Paranoia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Psychotic disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Schizoaffective disorder	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Schizophrenia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Substance abuse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Substance use disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Substance-induced mood disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Suicidal ideation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Psychiatric disorders Suicide attempt	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Alcoholic seizure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Altered state of consciousness	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrial fibrillation	0.07% 11/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 7/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 11/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 13/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 27/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Amnesia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Amyotrophic lateral sclerosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Arachnoid cyst	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ataxia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Balance disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Basal ganglia haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Brain stem haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Brain stem infarction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Carotid artery occlusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Carotid artery stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Carotid artery thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cauda equina syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Central nervous system lesion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebellar stroke	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebral infarction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebrovascular accident	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 7/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 8/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 12/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cerebrovascular disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cervical cord compression	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cervical radiculopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Cognitive disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Coma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Dementia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Dizziness	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Drug withdrawal convulsions	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Embolic stroke	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Encephalopathy	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Essential tremor	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Facial paralysis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Haemorrhage intracranial	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Haemorrhagic stroke	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Headache	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hemiparesis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hemiplegia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hemiplegic migraine	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hydrocephalus	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hypoaesthesia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Idiopathic partial epilepsy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Incoherent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Intracranial aneurysm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ischaemic stroke	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Lacunar stroke	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Lumbar radiculopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Migraine	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Multiple sclerosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Myasthenia gravis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Myelitis transverse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Myelopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Nerve compression	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Neuropathy peripheral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Optic neuritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Paraesthesia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Paralysis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Presyncope	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Radiculopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Sciatica	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Seizure	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Seizure like phenomena	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Sensory disturbance	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Speech disorder	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Spinal claudication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Spinal cord compression	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Stiff person syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Syncope	0.05% 7/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 10/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 13/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Thalamic infarction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Toxic encephalopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Transient global amnesia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Transient ischaemic attack	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 13/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Tremor	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Trigeminal neuralgia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Unresponsive to stimuli	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Vestibular migraine	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Amaurosis fugax	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Chorioretinopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Diplopia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Optic ischaemic neuropathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Retinal artery occlusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Retinal detachment	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Eye disorders Retinal tear	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Vertigo	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Vertigo positional	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac disorders	0.30% 45/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.29% 44/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 2/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.67% 85/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.53% 81/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.72% 142/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Acute coronary syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Acute left ventricular failure	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Acute myocardial infarction	0.04% 6/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 10/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 11/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.11% 21/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Angina pectoris	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 8/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Angina unstable	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 6/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Aortic valve incompetence	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Aortic valve stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Arrhythmia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Arteriosclerosis coronary artery	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Arteriospasm coronary	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrial flutter	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrial tachycardia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrioventricular block	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrioventricular block complete	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Atrioventricular block second degree	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Bradycardia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Bundle branch block left	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Bundle branch block right	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac arrest	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 9/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac failure	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac failure acute	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac failure chronic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac failure congestive	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 8/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 10/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 10/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiac flutter	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardio-respiratory arrest	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiogenic shock	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiomegaly	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiomyopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiopulmonary failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Cardiovascular disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Chronic left ventricular failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Coronary artery disease	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.12% 15/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 12/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 18/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Coronary artery insufficiency	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Coronary artery occlusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Coronary artery stenosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Ischaemic cardiomyopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Left ventricular failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Microvascular coronary artery disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Mitral valve incompetence	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Mitral valve prolapse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Mitral valve stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Myocardial infarction	0.07% 10/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 8/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 6/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 8/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 14/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Myocardial ischaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Myocarditis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Palpitations	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Paroxysmal atrioventricular block	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Pericardial effusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Pericarditis	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Pulseless electrical activity	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Sinoatrial block	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Sinus node dysfunction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Sinus tachycardia	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Stress cardiomyopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Supraventricular tachycardia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Ear and labyrinth disorders Tachycardia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Arteriosclerosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Axillary vein thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Deep vein thrombosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 7/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Embolism venous	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Extremity necrosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Fibromuscular dysplasia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Haematoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypertension	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypertensive crisis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypertensive emergency	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypertensive urgency	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypotension	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 8/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Hypovolaemic shock	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Intermittent claudication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Ischaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Jugular vein thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders May-Thurner syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Orthostatic hypotension	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Pelvic venous thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral artery aneurysm	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral artery occlusion	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral artery thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral ischaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Peripheral vascular disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Polyarteritis nodosa	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Shock	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Shock haemorrhagic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Subclavian vein thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Thrombophlebitis superficial	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Thrombosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Vascular disorders Venous thrombosis limb	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Emphysema	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.08% 12/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 7/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.05% 8/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal spasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.05% 7/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 11/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 11/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 16/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal hernia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal mass	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal pain	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal pain lower	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Cannabinoid hyperemesis syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Chronic gastritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Colitis	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Constipation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Crohn's disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Dental caries	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Death	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Diarrhoea	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Diverticular perforation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Diverticulum	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Dysphagia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Enteritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Enterocolitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastric fistula	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastric perforation	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastric ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastritis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Haematemesis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Haematochezia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Hiatus hernia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Ileal perforation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Ileus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Inguinal hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Internal hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intestinal perforation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intestinal pseudo-obstruction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Intussusception	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Large intestine perforation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Lumbar hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Nausea	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Oesophageal rupture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Pancreatitis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Rectal fissure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Rectal prolapse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Rectal ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Small intestinal obstruction	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 10/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Terminal ileitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Tooth socket haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Volvulus	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Gastrointestinal disorders Vomiting	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Bile duct stone	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Biliary colic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Biliary dyskinesia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholangitis acute	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholecystitis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 8/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholecystitis acute	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholelithiasis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholelithiasis obstructive	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Cholestasis of pregnancy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Hepatic cyst	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Hepatic failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Hepatic lesion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Skin and subcutaneous tissue disorders	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Acute generalised exanthematous pustulosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Angioedema	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Decubitus ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Dermatitis bullous	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Drug eruption	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Erythema nodosum	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Excessive skin	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Rash	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Rash vesicular	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Hepatobiliary disorders Skin ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Connective tissue disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Flank pain	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 4/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Jaw disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Muscular weakness	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Chronic kidney disease	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.13% 19/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.08% 12/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.24% 30/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.14% 21/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.11% 21/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Pain in extremity	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spinal synovial cyst	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Acute kidney injury	0.04% 6/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.06% 7/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.07% 10/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 9/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Azotaemia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Bladder prolapse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Bladder spasm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Haematuria	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Hydronephrosis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Hypertonic bladder	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Nephritis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Nephrolithiasis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.09% 11/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal cyst	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal aneurysm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal artery stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal impairment	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Ureterolithiasis	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Ureteric obstruction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Urinary retention	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Renal and urinary disorders Urogenital fistula	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 6/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 8/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Foetal hypokinesia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Morning sickness	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Premature rupture of membranes	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Pregnancy, puerperium and perinatal conditions Prolonged pregnancy	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Adenomyosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Cervical dysplasia	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Cervix haemorrhage uterine	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Endometriosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Menorrhagia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Ovarian cyst	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Ovarian cyst torsion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Pelvic pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Pelvic prolapse	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Prostatitis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Prostatomegaly	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Uterine prolapse	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Congenital, familial and genetic disorders	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Arnold-Chiari malformation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Talipes	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Reproductive system and breast disorders Vitello-intestinal duct remnant	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Asthenia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Chest discomfort	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Chest pain	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 6/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Drug withdrawal syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Fatigue	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Feeling hot	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Generalised oedema	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Hyperthermia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Impaired healing	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Incarcerated hernia	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Medical device pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Multiple organ dysfunction syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Non-cardiac chest pain	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 6/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Oedema peripheral	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Procedural failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Pyrexia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Strangulated hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Sudden death	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Swelling face	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Systemic inflammatory response syndrome	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Vascular stent stenosis	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Investigations	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 4/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Ammonia increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Anticoagulation drug level above therapeutic	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Blood pressure increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Ejection fraction decreased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Heart rate decreased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Heart rate irregular	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Hepatic enzyme increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Hormone level abnormal	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Liver function test increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Myocardial necrosis marker increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Platelet count decreased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Transaminases increased	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Weight increased	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Anaemia postoperative	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Animal bite	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Ankle fracture	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 6/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Back injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Cartilage injury	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Central cord syndrome	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Concussion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Contusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Face injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Fall	0.03% 5/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.05% 9/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 4/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Femur fracture	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 5/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Foreign body ingestion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Gun shot wound	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Head injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Hip fracture	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Immunisation anxiety related reaction	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Incision site pain	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Joint injury	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Limb injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Open fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Open globe injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Overdose	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Pelvic bone injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural fever	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural hypotension	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post procedural urine leak	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Procedural haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Rib fracture	0.02% 3/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.03% 5/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Road traffic accident	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 7/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Seroma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Skin laceration	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Snake bite	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Stab wound	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Sternal fracture	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Superficial injury of eye	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.04% 1/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 2/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Traumatic haemothorax	0.01% 2/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Ureteric injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 2/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Abdominoplasty	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Liposuction	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Mammoplasty	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Social circumstances	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Physical assault	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Sexual abuse	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Product issues	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.02% 3/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Device dislocation	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Device electrical impedance issue	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Device failure	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Device loosening	0.00% 0/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.01% 1/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Surgical and medical procedures Lead dislodgement	0.01% 1/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.

Other adverse events

Measure	Part A (Blinded): Placebo n=15162 participants at risk Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29).	Part A (Blinded): mRNA-1273 n=15184 participants at risk Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29).	Part B (Open-label): Placebo n=2513 participants at risk Participants received placebo on a 2-dose injection schedule in Part A and did not receive mRNA-1273 in Part B.	Part B (Open-label): Placebo/mRNA-1273 n=12649 participants at risk Participants received placebo on a 2-dose injection schedule in Part A and received 100 μg mRNA-1273 in Part B.	Part B (Open-label): mRNA-1273 n=15184 participants at risk Participants received mRNA-1273 on a 2-dose injection schedule in Part A and continued follow-up in Part B.	Part C: mRNA-1273 Booster n=19609 participants at risk Participants received 50 μg mRNA-1273 booster.
Infections and infestations COVID-19	6.2% 947/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.61% 92/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.84% 21/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	3.9% 489/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	4.3% 650/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	24.9% 4885/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Infections and infestations Upper respiratory tract infection	2.4% 361/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.0% 305/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.72% 18/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	3.5% 441/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	3.2% 491/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	5.2% 1017/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
Nervous system disorders Headache	6.9% 1046/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	7.2% 1087/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.16% 4/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	3.0% 384/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	1.3% 200/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	5.9% 1150/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Fatigue	6.3% 954/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	7.1% 1078/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.24% 6/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.7% 343/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.93% 141/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	7.7% 1515/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.
General disorders Injection site pain	1.1% 165/15162 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	2.2% 327/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.00% 0/2513 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	4.4% 559/12649 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	0.30% 45/15184 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.	14.1% 2764/19609 • up to Day 759 (end of study) All-cause Mortality: Randomized Set for Part A \& Safety Sets for Parts B\&C.SAEs/"other" AEs: Safety Sets for Parts A\&B\&C. Part A collection: 1st dose to PDV/unblinding/BD/last date observed, whichever was earliest, up to Day 759 Part B collection: PDV/unblinding at 4 months to BD/last date observed, whichever was earliest, up to Day 759 Part C collection: BD through Day 759 Note, not all solicited ARs considered AEs. Investigator determined if solicited AR was also to be recorded as an AE.

Additional Information

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